510(k) K962298
- Device
- CENTER OPTICAL GLASSES
- Applicant
- MIRAGE EYEWEAR, INC.
- 510(k) number
- K962298
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-25
- Date received
- 1996-06-13
- 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
- FU-LIN HU
- Address
- 961 Meridian Ave. Alhambra CA US 91803 91803
FDA Registration Numbers#
- 8043830
- 3015483699
- 3005147601
- 3026979361
- 3015276840
- 3009781427
- 3027135885
- 3011271484
- 3044779075
- 3033011342
- 9617474
- 3023863251
- 3015969621
- 3004086204
- 3006203695
- 3031635931
- 9615131
- 3012931104
- 3011914147
- 3013170369
- 3022808
- 3012995440
- 3030365815
- 3009317586
- 2438600
- 3017952336
- 3030516433
- 3038289343
- 3004134915
- 1000203163
- 3013410776
- 3003691964
- 1000300091
- 3017101317
- 9614887
- 3017122860
- 3030514700
- 8043097
- 3020602066
- 3004138487
- 3012851284
- 3017305937
- 3032684784
- 3019492261
- 3012186586
- 3015136941
- 3009444820
- 3011710819
- 3007607674
- 3010774780
- 3004504721
- 9681480
- 3015339698
- 3038613813
- 3025055228
- 2532089
- 3025763803
- 8010214
- 3003845599
- 3015462333
- 9615466
- 1421424
- 3005279245
- 3042157026
- 3045857232
- 3012980312
- 3043648613
- 3019021940
- 3044688589
- 3010923108
- 3027307777
- 3006034212
- 3027660589
- 3005499942
- 3010435017
- 3016931719
- 3030386175
- 3009943650
- 3008311442
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases