510(k) K931408
- Device
- SUNGLASSES
- Applicant
- SUNNYCRAFT PHILIPPINES, INC.
- 510(k) number
- K931408
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-10-01
- Date received
- 1993-03-19
- 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
- EDWARD TANG
- Address
- 8th Floor , Quad Alpha Centrum Bldg., 125 Pioneer St. Mandaluyong City PH
FDA Registration Numbers#
- 3043177860
- 1218954
- 3004848970
- 3002518348
- 3009005492
- 3016232394
- 3018153150
- 3009455348
- 3004116534
- 3013556952
- 3014159488
- 3017649333
- 3009090949
- 3005391450
- 3006181471
- 3014016129
- 3010919188
- 3008598038
- 3023338978
- 3015220770
- 3013170369
- 3011015142
- 2031962
- 3008370976
- 3013219284
- 3008057020
- 3040999150
- 3004167027
- 3024987631
- 3017069344
- 1062873
- 3040387972
- 3032246460
- 3043179616
- 3021376099
- 3014715781
- 3013688041
- 3005236311
- 3009278339
- 3008388363
- 3012937063
- 3010502837
- 3009035473
- 9710339
- 3015169733
- 3020602066
- 3010990456
- 8040448
- 3011544981
- 3044897057
- 3006984884
- 3005035719
- 3011157249
- 3014539734
- 3018015415
- 3012824852
- 8043304
- 3015926590
- 9615704
- 3009492367
- 3008111569
- 9680369
- 3010069263
- 3012498117
- 9615664
- 3019889623
- 9680411
- 3014308107
- 3011191563
- 3004868401
- 3044465767
- 3000159466
- 3017865175
- 9615055
- 3012409043
- 3015092134
- 3017767230
- 3017889035
- 3017956124
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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