510(k) K971465
- Device
- NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
- Applicant
- NATIONAL HEALTHCARE MFG. CORP.
- 510(k) number
- K971465
- Product code
- HOY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-04
- Date received
- 1997-04-22
- Regulation
- 886.4750
- Classification name
- Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code HOY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132042 | AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND | X6d, Ltd. | 2014-04-28 |
| K050856 | LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM | Ophthocare , Ltd. | 2005-05-31 |
| K944700 | ARCTIC PREMIER SERIES | Sungold Eyewear, Inc. | 1994-12-22 |
| K944857 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | 1994-12-15 |
| K945351 | SHIELD, EYE, OPHTHALMIC | Taiwan Eva Industrial Co., Inc. | 1994-12-13 |
| K945346 | MAKROLON 2405 GOGGLES (LIGHT AND DARK) | Universal Massage & Tanning, Inc. | 1994-11-22 |
| K942407 | AMCON SLIP IN MYDRIATIC SUNGLASSES | Amcon Laboratories, Inc. | 1994-06-06 |
| K941829 | SUN FILTERS/SHIELDS | Klinger Eye Shields, Inc. | 1994-05-17 |
| K930347 | SHAIDS PROTECTIVE GLASSES | Depuy, Inc. | 1994-04-29 |
| K940213 | UNIVERSAL CUSHIONED METAL EYE SHIELD | P.J. Products, Inc. | 1994-03-24 |
| K940275 | UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD | P.J. Products, Inc. | 1994-03-24 |
| K930840 | POST-MYDS(TM) | Aukland Medical Plastics, Inc. | 1994-03-01 |
| K940095 | FOX EYE ALUMINUM SHIELD, OPHTHALMIC | P.J. Products, Inc. | 1994-03-01 |
| K931254 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | 1993-11-12 |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | American Threshold Industries, Inc. | 1993-11-12 |
Legacy Summary#
summary
FDA Review#
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