510(k) K885275
- Device
- ASSENAT-BLESCHET SUNGLASSES
- Applicant
- ROSEBURG SA
- 510(k) number
- K885275
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-24
- Date received
- 1988-12-27
- 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
- DARIENNE MOYER
- Address
- Suite 120 Canal Sq. 1054 31st St. NW Washington DC US 20007 20007
FDA Registration Numbers#
- 3011277099
- 3012376402
- 9616258
- 1221470
- 3010502837
- 3010613909
- 3042972016
- 3040312681
- 3018017855
- 3016671478
- 3017889035
- 3023876592
- 3027650110
- 3006985123
- 3031461748
- 3011164728
- 3027436348
- 9615448
- 3008004470
- 3016661538
- 3032027177
- 3015169733
- 8020623
- 3027307777
- 3042285589
- 3026654653
- 3013767433
- 3003951061
- 3006573171
- 3014888885
- 3042870833
- 3011505252
- 3013957868
- 3027395807
- 3021194551
- 3003805077
- 3021926669
- 3025328693
- 3026295188
- 3013293162
- 3007930715
- 9681256
- 3003582502
- 3011528358
- 8020823
- 3018161212
- 3015926590
- 3017432615
- 3024748169
- 3042254864
- 3009765418
- 3007694987
- 2087417
- 3019783817
- 3007667067
- 8040195
- 3012978407
- 3032626101
- 9614310
- 3013507321
- 3022121580
- 3014171026
- 3008103948
- 3017896942
- 8031615
- 3030185575
- 3021564436
- 3009943650
- 3030684427
- 3013506923
- 3012980312
- 9616532
- 9615810
- 2437850
- 3006646498
- 3003915547
- 3012119296
- 3012661489
- 3031606441
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#
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