510(k) K974045
- Device
- VENNETO
- Applicant
- AMSURE SPORTS, INC.
- 510(k) number
- K974045
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-20
- Date received
- 1997-10-24
- 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
- WENDY W.C. SIU
- Address
- 1818 Naio St., Suite B Honolulu HI US 96817 96817
FDA Registration Numbers#
- 3038310426
- 3013720241
- 3017970305
- 3028674572
- 3043013261
- 3031232520
- 3016099060
- 3013742501
- 8021538
- 3044737675
- 3010862420
- 3009492367
- 3031461748
- 3005067827
- 3013589088
- 3003582502
- 3014326379
- 3008057020
- 3002685691
- 9615527
- 9617808
- 3027200011
- 3010908619
- 3014527836
- 3016595584
- 3038134332
- 3008715571
- 3007719542
- 3008517911
- 3016170487
- 3038284246
- 3011140418
- 3011307306
- 3015446923
- 3018999226
- 3017896942
- 1000244862
- 3010613909
- 3003845599
- 3006946090
- 3014403943
- 3015483699
- 3027395630
- 3031635931
- 3012661489
- 3042953191
- 3041033142
- 3007421138
- 8043542
- 3007699038
- 3029897827
- 3009353336
- 3010149266
- 3007802463
- 3018015415
- 3014023477
- 8022547
- 3006223090
- 3003799587
- 3035105287
- 3012263937
- 3016812022
- 1937310
- 3030334116
- 3033436402
- 9710482
- 3012065550
- 3014889445
- 3004489794
- 3007065619
- 8021087
- 3006347596
- 3011277099
- 3004899508
- 3013820608
- 3010367673
- 3012418798
- 3014242973
- 3002900744
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 |
| 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 |
| K973407 | SUNGLASSES (NON-PRESCRIPTION) | Pacific Optical Co. , Ltd. | 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 |
Legacy Summary#
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FDA Review#
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