The following data is part of a premarket notification filed by Women First Healthcare, Inc. with the FDA for Scc-23 Safety Clamp And Cutter.
| Device ID | K982464 |
| 510k Number | K982464 |
| Device Name: | SCC-23 SAFETY CLAMP AND CUTTER |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | WOMEN FIRST HEALTHCARE, INC. 12220 EL CAMINO REAL, SUITE 400 San Diego, CA 92130 |
| Contact | Jeanne-marie Varge |
| Correspondent | Jeanne-marie Varge WOMEN FIRST HEALTHCARE, INC. 12220 EL CAMINO REAL, SUITE 400 San Diego, CA 92130 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-15 |
| Decision Date | 1998-08-11 |
| Summary: | summary |