510(k) K934402
- Device
- Cool Kids Mirror Shades
- Applicant
- JA-RU, INC.
- 510(k) number
- K934402
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-25
- Date received
- 1993-09-09
- 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
- JACK SELEVAN
- Address
- 4030 Phillips Hwy. Jacksonville FL US 32207 32207
FDA Registration Numbers#
- 3008524117
- 3043648613
- 3004080633
- 3000180670
- 8040201
- 3014670278
- 3008517911
- 3032027177
- 3007817071
- 3009831516
- 3009158340
- 9616413
- 3008350694
- 3044855013
- 3015392301
- 9681584
- 3016411953
- 3017411104
- 3011914147
- 3005982781
- 3013035024
- 3030445476
- 3005043807
- 3012824852
- 3017296478
- 3017956124
- 3013523350
- 3021566196
- 3008971259
- 3012741123
- 3045824817
- 3014889445
- 3033891197
- 3010142106
- 3031599350
- 3010184873
- 3008345156
- 3015437136
- 3042972016
- 3010168508
- 3038613813
- 3021292813
- 3011644027
- 3010435017
- 8043274
- 3012202690
- 3014171026
- 3004305946
- 3009770970
- 3006472348
- 3015829399
- 3005311378
- 1000481099
- 3048246487
- 3043152400
- 3014872034
- 3006748697
- 3034565743
- 3023010371
- 9617812
- 3003590111
- 3013709019
- 3033796882
- 3008727534
- 3009961710
- 3017952336
- 3002226145
- 9681600
- 3003096749
- 3038279561
- 3026295188
- 3019841089
- 3015126404
- 3013524156
- 1000484722
- 3007582638
- 3018267425
- 8043648
- 3007774522
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 |