The following data is part of a premarket notification filed by Medicfit Technology Sdn Bhd with the FDA for Male Circumcision Kits:rapideclamp.
| Device ID | K142163 |
| 510k Number | K142163 |
| Device Name: | MALE CIRCUMCISION KITS:RAPIDECLAMP |
| Classification | Clamp, Circumcision |
| Applicant | MEDICFIT TECHNOLOGY SDN BHD 55 NORTHERN BLVD Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah MEDICFIT TECHNOLOGY SDN BHD 55 NORTHERN BLVD Great Neck, NY 11021 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-06 |
| Decision Date | 2015-04-20 |
| Summary: | summary |