The following data is part of a premarket notification filed by Sterile Concepts, Inc. with the FDA for Ob/gyn Packs.
| Device ID | K951081 |
| 510k Number | K951081 |
| Device Name: | OB/GYN PACKS |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond, VA 23234 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond, VA 23234 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-11-13 |