The following data is part of a premarket notification filed by Meluna with the FDA for Meluna Classic/sport Menstrual Cup.
| Device ID | K140626 |
| 510k Number | K140626 |
| Device Name: | MELUNA CLASSIC/SPORT MENSTRUAL CUP |
| Classification | Cup, Menstrual |
| Applicant | MELUNA 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Yolanda Smith MELUNA 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-11 |
| Decision Date | 2014-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B415CSXS200 | K140626 | 000 |
| B415CSMS100 | K140626 | 000 |
| B415CSMS000 | K140626 | 000 |
| B415CSMR200 | K140626 | 000 |
| B415CSMR100 | K140626 | 000 |
| B415CSMR000 | K140626 | 000 |
| B415CSMB200 | K140626 | 000 |
| B415CSMB100 | K140626 | 000 |
| B415CSMB000 | K140626 | 000 |
| B415CSLS200 | K140626 | 000 |
| B415CSLS100 | K140626 | 000 |
| B415CSLS000 | K140626 | 000 |
| B415CSLR200 | K140626 | 000 |
| B415CSLR100 | K140626 | 000 |
| B415CSLR000 | K140626 | 000 |
| B415CSLB200 | K140626 | 000 |
| B415CSLB100 | K140626 | 000 |
| B415CSMS200 | K140626 | 000 |
| B415CSSB000 | K140626 | 000 |
| B415CSXS100 | K140626 | 000 |
| B415CSXS000 | K140626 | 000 |
| B415CSXR200 | K140626 | 000 |
| B415CSXR100 | K140626 | 000 |
| B415CSXR000 | K140626 | 000 |
| B415CSXB200 | K140626 | 000 |
| B415CSXB100 | K140626 | 000 |
| B415CSXB000 | K140626 | 000 |
| B415CSSS200 | K140626 | 000 |
| B415CSSS100 | K140626 | 000 |
| B415CSSS000 | K140626 | 000 |
| B415CSSR200 | K140626 | 000 |
| B415CSSR100 | K140626 | 000 |
| B415CSSR000 | K140626 | 000 |
| B415CSSB200 | K140626 | 000 |
| B415CSSB100 | K140626 | 000 |
| B415CSLB000 | K140626 | 000 |
| B415CPXS200 | K140626 | 000 |
| B415CPMS100 | K140626 | 000 |
| B415CPMS000 | K140626 | 000 |
| B415CPMR200 | K140626 | 000 |
| B415CPMR100 | K140626 | 000 |
| B415CPMR000 | K140626 | 000 |
| B415CPMB200 | K140626 | 000 |
| B415CPMB100 | K140626 | 000 |
| B415CPMB000 | K140626 | 000 |
| B415CPLS200 | K140626 | 000 |
| B415CPLS100 | K140626 | 000 |
| B415CPLS000 | K140626 | 000 |
| B415CPLR200 | K140626 | 000 |
| B415CPLR100 | K140626 | 000 |
| B415CPLR000 | K140626 | 000 |
| B415CPLB200 | K140626 | 000 |
| B415CPLB100 | K140626 | 000 |
| B415CPMS200 | K140626 | 000 |
| B415CPSB000 | K140626 | 000 |
| B415CPXS100 | K140626 | 000 |
| B415CPXS000 | K140626 | 000 |
| B415CPXR200 | K140626 | 000 |
| B415CPXR100 | K140626 | 000 |
| B415CPXR000 | K140626 | 000 |
| B415CPXB200 | K140626 | 000 |
| B415CPXB100 | K140626 | 000 |
| B415CPXB000 | K140626 | 000 |
| B415CPSS200 | K140626 | 000 |
| B415CPSS100 | K140626 | 000 |
| B415CPSS000 | K140626 | 000 |
| B415CPSR200 | K140626 | 000 |
| B415CPSR100 | K140626 | 000 |
| B415CPSR000 | K140626 | 000 |
| B415CPSB200 | K140626 | 000 |
| B415CPSB100 | K140626 | 000 |
| B415CPLB000 | K140626 | 000 |
| B415SSXS200 | K140626 | 000 |
| B415SSMS100 | K140626 | 000 |
| B415SSMS000 | K140626 | 000 |
| B415SSMR200 | K140626 | 000 |
| B415SSMR100 | K140626 | 000 |
| B415SSMR000 | K140626 | 000 |
| B415SSMB200 | K140626 | 000 |
| B415SSMB100 | K140626 | 000 |
| B415SSMB000 | K140626 | 000 |
| B415SSLS200 | K140626 | 000 |
| B415SSLS100 | K140626 | 000 |
| B415SSLS000 | K140626 | 000 |
| B415SSLR200 | K140626 | 000 |
| B415SSLR100 | K140626 | 000 |
| B415SSLR000 | K140626 | 000 |
| B415SSLB200 | K140626 | 000 |
| B415SSLB100 | K140626 | 000 |
| B415SSMS200 | K140626 | 000 |
| B415SSS200 | K140626 | 000 |
| B415SSXS100 | K140626 | 000 |
| B415SSXS000 | K140626 | 000 |
| B415SSXR200 | K140626 | 000 |
| B415SSXR100 | K140626 | 000 |
| B415SSXR000 | K140626 | 000 |
| B415SSXB200 | K140626 | 000 |
| B415SSXB100 | K140626 | 000 |
| B415SSXB000 | K140626 | 000 |
| B415SSSS100 | K140626 | 000 |
| B415SSSS000 | K140626 | 000 |
| B415SSSR200 | K140626 | 000 |
| B415SSSR100 | K140626 | 000 |
| B415SSSR000 | K140626 | 000 |
| B415SSSB200 | K140626 | 000 |
| B415SSSB100 | K140626 | 000 |
| B415SSSB000 | K140626 | 000 |
| B415SSLB000 | K140626 | 000 |
| B415SPXS200 | K140626 | 000 |
| B415SPMS100 | K140626 | 000 |
| B415SPMS000 | K140626 | 000 |
| B415SPMR200 | K140626 | 000 |
| B415SPMR100 | K140626 | 000 |
| B415SPMR000 | K140626 | 000 |
| B415SPMB200 | K140626 | 000 |
| B415SPMB100 | K140626 | 000 |
| B415SPMB000 | K140626 | 000 |
| B415SPLS200 | K140626 | 000 |
| B415SPLS100 | K140626 | 000 |
| B415SPLS000 | K140626 | 000 |
| B415SPLR200 | K140626 | 000 |
| B415SPLR100 | K140626 | 000 |
| B415SPLR000 | K140626 | 000 |
| B415SPLB200 | K140626 | 000 |
| B415SPLB100 | K140626 | 000 |
| B415SPMS200 | K140626 | 000 |
| B415SPSB000 | K140626 | 000 |
| B415SPXS100 | K140626 | 000 |
| B415SPXS000 | K140626 | 000 |
| B415SPXR200 | K140626 | 000 |
| B415SPXR100 | K140626 | 000 |
| B415SPXR000 | K140626 | 000 |
| B415SPXB200 | K140626 | 000 |
| B415SPXB100 | K140626 | 000 |
| B415SPXB000 | K140626 | 000 |
| B415SPSS200 | K140626 | 000 |
| B415SPSS100 | K140626 | 000 |
| B415SPSS000 | K140626 | 000 |
| B415SPSR200 | K140626 | 000 |
| B415SPSR100 | K140626 | 000 |
| B415SPSR000 | K140626 | 000 |
| B415SPSB200 | K140626 | 000 |
| B415SPSB100 | K140626 | 000 |
| B415SPLB000 | K140626 | 000 |