510(k) K900944
- Device
- SUNGLASSES
- Applicant
- K MART APPAREL CORP.
- 510(k) number
- K900944
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-05
- Date received
- 1990-02-28
- Regulation
- 886.5850
- Classification name
- Sunglasses (non-prescription Including Photosensitive)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN M KOTT
- Address
- 7373 W. Side Ave. North Bergen NJ US 07047 07047
FDA Registration Numbers#
- 1000467313
- 3030386175
- 3045926218
- 3017160888
- 3004145424
- 3018011827
- 3049795615
- 3006752097
- 3012205178
- 3010862420
- 3012250042
- 3016241870
- 3016418134
- 3010508185
- 3026061685
- 3025328693
- 3007710647
- 3006748697
- 3033606211
- 3042228518
- 3020386049
- 3037025953
- 3009005492
- 3005516815
- 3013530119
- 3019009783
- 3013359319
- 3007607674
- 3012978407
- 3009943650
- 9680237
- 3009019665
- 3032684784
- 3006550126
- 3030192584
- 3007351543
- 3021612330
- 3010184873
- 3008745128
- 3003883279
- 3012424230
- 1000282694
- 3012436532
- 3013151253
- 3005982781
- 3016569244
- 9680160
- 3012088808
- 8040596
- 3009169953
- 8020823
- 3015483699
- 3010170531
- 9680301
- 3009005046
- 3003096749
- 3030319459
- 3043750579
- 3009410372
- 3006748327
- 1000402022
- 3049785975
- 3004116534
- 3017965799
- 1000431825
- 3009337032
- 3005043807
- 3032436225
- 3020970011
- 3040388420
- 3017649333
- 9615839
- 3015829399
- 3018703107
- 1000385428
- 3003949200
- 3042156934
- 8020627
- 8020623
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974852 | NON-PRESCRIPTION SUNGLASSES | Chia Hui Spectacles Mfg. Corp. | 1998-01-30 |
| K974860 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Ming Ming Optical Co. , Ltd. | 1998-01-30 |
| K974861 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Hindar Optical Co., Ltd. | 1998-01-27 |
| K974511 | SUNGLASSES | Sun World Intl., Inc. | 1998-01-12 |
| K974441 | SUNGLASSES | Hip Shing Fat Co., Ltd. | 1998-01-09 |
| K973528 | SUNGLASSES | Jeou Jeou Long Industrial Co., Ltd. | 1997-12-08 |
| K974414 | MULTI | Morning Calm Corp. | 1997-12-08 |
| K974179 | NON-PRESCRIPTION SUNGLASSES | Taipan Optical Company , Ltd. | 1997-12-01 |
| K974045 | VENNETO | Amsure Sports, Inc. | 1997-11-20 |
| K973934 | SUNGLASSES | Elegance Optical Manufactory, Ltd. | 1997-11-18 |
| K973526 | SUNGLASSES | Pyramid Handbags, Inc. | 1997-10-16 |
| K973407 | SUNGLASSES (NON-PRESCRIPTION) | Pacific Optical Co. , Ltd. | 1997-09-30 |
| K973490 | SUNGLASSES | Tong Yang Optical Co. | 1997-09-30 |
| K972850 | SUNGLASSES | Indoptica, S.A. | 1997-09-17 |
| K973016 | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS | Optimaxx Intl. | 1997-09-17 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases