510(k) K946256
- Device
- SUNGLASSES
- Applicant
- CHANEL, INC.
- 510(k) number
- K946256
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-01-17
- Date received
- 1994-12-23
- Regulation
- 886.5850
- Classification name
- Sunglasses (non-prescription Including Photosensitive)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BETH COHEN
- Address
- 5 E. 57th St. New York NY US 10022 10022
FDA Registration Numbers#
- 3004366388
- 3046007776
- 3031550993
- 3005094451
- 3012796531
- 1000413287
- 3010156702
- 3030185575
- 1000349389
- 3018074459
- 3032087869
- 3009132185
- 3003976094
- 3007620166
- 3024130952
- 3007526910
- 3029878675
- 3010952192
- 3043177860
- 3009666019
- 3016396119
- 3010613909
- 9615664
- 8043274
- 3003268108
- 3016775323
- 3003775404
- 3017122860
- 3011642909
- 3013167735
- 3010622264
- 3016595584
- 3031860701
- 3004409566
- 3011710819
- 3031182017
- 3015534053
- 9617804
- 3015992080
- 3018359975
- 2081012
- 3008675266
- 3014527914
- 8043542
- 3008863250
- 3010487482
- 3005519018
- 3010524351
- 3023876592
- 3010238287
- 3004167027
- 3015144200
- 3012981754
- 3045855261
- 3013510936
- 3006339969
- 1000347920
- 3018052478
- 3030979161
- 3042285066
- 3009858811
- 3010170531
- 3015335987
- 3014403943
- 3032299604
- 3007582677
- 3006600074
- 3030220352
- 3017952336
- 3012362305
- 3031583022
- 3039358566
- 3008513022
- 1064737
- 2084270
- 3003433048
- 3013837720
- 8022547
- 3007699038
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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