The following data is part of a premarket notification filed by National Healthcare Mfg. Corp. with the FDA for National Medical Halthcare Custom Ophthalmic Kits Or Trays.
| Device ID | K971465 |
| 510k Number | K971465 |
| Device Name: | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| 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 | HOY |
| Subsequent Product Code | HMX |
| Subsequent Product Code | HNM |
| Subsequent Product Code | HQR |
| Subsequent Product Code | KKX |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-22 |
| Decision Date | 1997-06-04 |
| Summary: | summary |