510(k) K930347
- Device
- Shaids Protective Glasses
- Applicant
- DEPUY, INC.
- 510(k) number
- K930347
- Product code
- HOY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-04-29
- Date received
- 1993-01-25
- Regulation
- 886.4750
- Classification name
- Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A KOTKOVETZ
- Address
- P.O. Box 988 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 1043646
- 3014161178
- 1530671
- 3006752097
- 3023152124
- 3013023735
- 3044150131
- 3043709869
- 3005022483
- 3032027578
- 3010272829
- 3015391081
- 3007735390
- 8022792
- 3014144373
- 3038134334
- 1000369642
- 3009072217
- 3017432615
- 3019567818
- 3013557562
- 3045891288
- 3009301500
- 3018703107
- 3010583458
- 9615399
- 3031369651
- 3010184873
- 3009491490
- 3009279940
- 1920664
- 2011171
- 9611462
- 2522949
- 2953696
- 3034565743
- 3008427684
- 3013293162
- 1526711
- 3025350033
- 3015456954
- 3023322473
- 3009831516
- 3008770252
- 3008384335
- 3038200636
- 3007192456
- 9680861
- 3004713654
- 3013130789
- 3011593607
- 8043441
- 3016087257
- 3040388420
- 3006982315
- 3011074933
- 3004860482
- 8043173
- 3031599350
- 3013556952
- 3007421138
- 3017435637
- 3005391805
- 3008111569
- 3030539818
- 3014444068
- 3003949200
- 3003491259
- 3014817722
- 1222993
- 3003902969
- 3010262284
- 3008044484
- 3013374101
- 1419844
- 8020623
- 2428983
- 3043177860
- 3012748937
Source Documents#
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 |
| K971465 | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | National Healthcare Mfg. Corp. | 1997-06-04 |
| 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 |
| 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 |