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#
- 3008111544
- 3043152400
- 3014872183
- 9616939
- 3017069344
- 3004126239
- 3031235934
- 3014444068
- 3004305946
- 3027556697
- 3015769077
- 3003757245
- 3011977991
- 3013532963
- 3012065550
- 3038320371
- 3023063901
- 3007165203
- 3006472348
- 1000349389
- 3012436532
- 3031590635
- 3042149901
- 9615466
- 3011642909
- 9616108
- 8043173
- 3006494408
- 3016099060
- 3010119835
- 3021244189
- 9681249
- 3007667067
- 3016929296
- 3043748032
- 3030466013
- 3010238287
- 3043177860
- 1064737
- 3006223090
- 9617805
- 3008241164
- 3030319459
- 3007120545
- 3014533659
- 3003590111
- 3008103948
- 2020853
- 3007290476
- 3035385768
- 3013589088
- 3004134915
- 3007802463
- 3015168599
- 3013183112
- 3005391450
- 3038134334
- 2111760
- 3006707030
- 3010952192
- 3008971259
- 3015282707
- 3015534053
- 3004193468
- 9617808
- 3012381607
- 3010399203
- 3010663789
- 3007085113
- 2434074
- 3017130991
- 3012083724
- 3048148434
- 3015172983
- 3010610971
- 3005519018
- 3011803475
- 3011716782
- 3008770645
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 |
| 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 |