510(k) K973934
- Device
- SUNGLASSES
- Applicant
- ELEGANCE OPTICAL MANUFACTORY, LTD.
- 510(k) number
- K973934
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-18
- Date received
- 1997-10-15
- 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
- ESTER LAI
- Address
- 401 Broadway, Suite 613 New York NY US 10013 10013
FDA Registration Numbers#
- 3014570166
- 3012741123
- 3011770145
- 3008386507
- 2319457
- 3012395063
- 3010865508
- 3004305946
- 2031962
- 3007865200
- 3039321715
- 3003433048
- 3034695202
- 3030510804
- 3030234168
- 3008103948
- 3018703107
- 3011644027
- 3013040322
- 3016232394
- 3010399203
- 3010087945
- 3038597556
- 3011835632
- 3003488848
- 3023152124
- 3042284339
- 3016170487
- 3024130952
- 2936829
- 3005135579
- 9615035
- 9614871
- 9681241
- 3009262638
- 3012463850
- 3008863250
- 3013561974
- 8021538
- 9681584
- 3017767230
- 3023618457
- 3030445476
- 3031599350
- 3008044481
- 3013170369
- 3006400929
- 3015220770
- 1000387127
- 3012842398
- 3030580282
- 3038284246
- 3013507321
- 3043013261
- 3010192570
- 3012240481
- 3043051410
- 3004134915
- 9681818
- 1000467313
- 3005519018
- 3013546276
- 3012937063
- 3008770645
- 9617617
- 3025510177
- 9615180
- 2083323
- 3015144200
- 3030090215
- 3004899508
- 3040312681
- 3004415169
- 3006532764
- 3002900586
- 3007192456
- 3027650110
- 3016241870
- 3015057669
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 |
| 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 |
| K972717 | RUFF WORK EYEGEAR | Ruff House, Inc. | 1997-08-25 |
Legacy Summary#
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FDA Review#
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