The following data is part of a premarket notification filed by National Healthcare Mfg. Corp. with the FDA for National Medical Healthcare Custom Orthopedic Kits And Trays.
| Device ID | K971317 |
| 510k Number | K971317 |
| Device Name: | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | NATIONAL HEALTHCARE MFG. CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula NATIONAL HEALTHCARE MFG. CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-09 |
| Decision Date | 1997-05-08 |
| Summary: | summary |