510(k) K973407
- Device
- Sunglasses (non-prescription)
- Applicant
- PACIFIC OPTICAL CO. LTD.
- 510(k) number
- K973407
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-30
- Date received
- 1997-09-09
- 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 WANG
- Address
- #90, Hong Dian Rd., S. Wenzhou, Zhejiang CN 325003 325003
FDA Registration Numbers#
- 3021271493
- 3013688041
- 3003915547
- 1000189446
- 3031550993
- 3004971437
- 3006532764
- 3042970887
- 3030192584
- 3012294556
- 3005135579
- 9611602
- 3009585785
- 3034211159
- 3043750614
- 9615055
- 3016170487
- 3012263937
- 3005623341
- 3038279070
- 3013819854
- 3010774780
- 2020853
- 3033436402
- 3003616231
- 3003883279
- 3016099060
- 3010622264
- 3010170531
- 3029897827
- 3012520513
- 3006942545
- 3010801778
- 3012981754
- 3007202698
- 3012483227
- 2111760
- 3043179616
- 3004833103
- 3011321733
- 3011544981
- 3005516815
- 3030989308
- 3012205178
- 3017276640
- 3009353336
- 3006669350
- 3037047283
- 3039358566
- 3013507321
- 3009762272
- 8043097
- 3009515549
- 1000454074
- 3031437350
- 1831687
- 3018064274
- 1000318396
- 3003249384
- 3007085113
- 9680176
- 3010629043
- 9680861
- 3015892222
- 3025822227
- 9617808
- 3038208112
- 3032626101
- 3007694987
- 3027718325
- 8040277
- 3011015142
- 3005499942
- 3008309602
- 8030271
- 3013124682
- 3021513649
- 3017599534
- 3010584251
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974860 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Ming Ming Optical Co. , Ltd. | 1998-01-30 |
| K974852 | NON-PRESCRIPTION SUNGLASSES | Chia Hui Spectacles Mfg. Corp. | 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 |
| K974414 | MULTI | Morning Calm Corp. | 1997-12-08 |
| K973528 | SUNGLASSES | Jeou Jeou Long Industrial Co., Ltd. | 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 |
| K973490 | SUNGLASSES | Tong Yang Optical Co. | 1997-09-30 |
| K973016 | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS | Optimaxx Intl. | 1997-09-17 |
| K972850 | SUNGLASSES | Indoptica, S.A. | 1997-09-17 |
| K972717 | RUFF WORK EYEGEAR | Ruff House, Inc. | 1997-08-25 |