The following data is part of a premarket notification filed by National Healthcare Mfg. Corp. with the FDA for National Medical Healthcare Custom Ob/gyn Kits, Trays, Or Packs.
| Device ID | K972013 |
| 510k Number | K972013 |
| Device Name: | NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | NATIONAL HEALTHCARE MFG. CORP. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula NATIONAL HEALTHCARE MFG. CORP. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-30 |
| Decision Date | 1997-08-26 |
| Summary: | summary |