510(k) K873966
- Device
- SUNGLASSES (NONPRESCRIPTION)
- Applicant
- SWANK PLUS LTD.
- 510(k) number
- K873966
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-26
- Date received
- 1987-09-29
- 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
- CIDER LAI
- Address
- P.O. Box 70750 Kowloon Central Post Office Hong Kong HK
FDA Registration Numbers#
- 9681547
- 3014570166
- 3012788416
- 3010595570
- 3005391450
- 3003799587
- 3011328755
- 3045891288
- 3007694987
- 3044736402
- 3004715562
- 3041033142
- 3042370512
- 3034629647
- 3006713791
- 3015168599
- 3013575784
- 3035708532
- 3016746538
- 3016470001
- 9617474
- 3011140418
- 3003840624
- 3027619151
- 3008111569
- 3011674724
- 3038208112
- 3010919188
- 3038136215
- 3004875810
- 3019783817
- 3012362305
- 9615527
- 3012741123
- 3002719961
- 3040388420
- 3012980312
- 3012842398
- 3011803475
- 9680301
- 9710448
- 3027341447
- 3008755352
- 8022542
- 8022779
- 3008496560
- 3016218289
- 2032543
- 3018015415
- 3038134332
- 3001551265
- 3009337032
- 3027650110
- 3007334777
- 3019889623
- 3009407759
- 3014670278
- 3004620771
- 3013410754
- 9616318
- 3009824078
- 8043542
- 3007502227
- 3017130991
- 3030194786
- 3004971437
- 2936829
- 3010229247
- 3016244741
- 3025583951
- 8022792
- 3010693499
- 3014159488
- 3048246487
- 3011268445
- 8020552
- 3010865508
- 3004704659
- 3005311378
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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