K951081 is an FDA 510(k) clearance for the OB/GYN PACKS. This device is classified as a Instrument, Manual, Specialized Obstetric-gynecologic (Class II - Special Controls, product code KNA).
Submitted by Sterile Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on November 13, 1995, 249 days after receiving the submission on March 9, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K951081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1995 |
| Decision Date | November 13, 1995 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNA — Instrument, Manual, Specialized Obstetric-gynecologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |