The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Swabcap And Swabflush.
| Device ID | K130975 |
| 510k Number | K130975 |
| Device Name: | SWABCAP AND SWABFLUSH |
| Classification | Cap, Device Disinfectant |
| Applicant | EXCELSIOR MEDICAL CORP. 555 13TH STREET, NW Washington, DC 20004 |
| Contact | Michael Heyl |
| Correspondent | Michael Heyl EXCELSIOR MEDICAL CORP. 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | QBP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-08 |
| Decision Date | 2013-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888277675886 | K130975 | 000 |
| 40612479261639 | K130975 | 000 |
| 30612479261656 | K130975 | 000 |
| 20363807000005 | K130975 | 000 |
| 20363807000012 | K130975 | 000 |
| 20363807000029 | K130975 | 000 |
| 20363807103010 | K130975 | 000 |
| 20363807103355 | K130975 | 000 |
| 20363807103553 | K130975 | 000 |
| 10887709082158 | K130975 | 000 |
| 10887709082172 | K130975 | 000 |
| 10888277675865 | K130975 | 000 |
| 10888277675872 | K130975 | 000 |
| 30887709097101 | K130975 | 000 |