K941641 is an FDA 510(k) clearance for the DISPOSABLE EMERGENCY OBSTETRICAL KIT. This device is classified as a Instrument, Manual, Specialized Obstetric-gynecologic (Class II - Special Controls, product code KNA).
Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on October 3, 1994, 182 days after receiving the submission on April 4, 1994.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K941641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1994 |
| Decision Date | October 03, 1994 |
| Days to Decision | 182 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 |