510(k) K953627
- Device
- New Sun Optical Non Prescription Sunglasses
- Applicant
- NEW SUN OPTICAL ENTERPRISE CO., LTD.
- 510(k) number
- K953627
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-10-25
- Date received
- 1995-07-31
- 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
- JUDY AWANA
- Address
- # 105 Tzu Chang Rd. Yung Kang Hsiang Taiwan Hsien TW
FDA Registration Numbers#
- 3011930885
- 2087075
- 3004116075
- 3004938952
- 3018161205
- 3013338532
- 1000265387
- 3016244798
- 3035105287
- 3006752097
- 3015968624
- 3038622486
- 3032684784
- 3007674720
- 3006472348
- 3001135633
- 2432297
- 3011164728
- 3006573171
- 3011803475
- 9615448
- 1225043
- 3004201350
- 3007774542
- 3015057669
- 1000385428
- 3000308604
- 3025590466
- 3015727308
- 3008137594
- 3003637017
- 3015112437
- 1000467313
- 3011786416
- 8022542
- 2111760
- 3006750143
- 3005893930
- 3015341507
- 3013091260
- 3010781306
- 3011818825
- 3009266621
- 3010487482
- 3003775404
- 3025822227
- 3012937100
- 3010182645
- 3009005492
- 3005516815
- 3007186430
- 3009296226
- 3022808
- 3002518348
- 3005615323
- 3043149890
- 3016261211
- 1421424
- 3016812022
- 3031550993
- 9680176
- 3006984884
- 3012164338
- 3032436225
- 3025583951
- 3004080633
- 3015414993
- 3019492261
- 9616441
- 3009781427
- 3015009277
- 3027057394
- 3006026515
- 3003757245
- 3025112745
- 3012602011
- 3030538356
- 3007517869
- 3031182194
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 |
| 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 |