K972013 is an FDA 510(k) clearance for the NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS. This device is classified as a Instrument, Manual, Specialized Obstetric-gynecologic (Class II - Special Controls, product code KNA).
Submitted by National Healthcare Mfg. Corp. (Great Neck, US). The FDA issued a Cleared decision on August 26, 1997, 88 days after receiving the submission on May 30, 1997.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K972013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1997 |
| Decision Date | August 26, 1997 |
| Days to Decision | 88 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 |