510(k) K963968
- Device
- FLYWAY
- Applicant
- LOOK STYLE, S.R.L.
- 510(k) number
- K963968
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-19
- Date received
- 1996-10-03
- 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
- TIBERIO GIORGIO
- Address
- Via S. Giovanni N. 56 Calalzo Di Cadore, (Bl) IT 32042 32042
FDA Registration Numbers#
- 3014449259
- 2020853
- 3007774542
- 3010266420
- 3008955813
- 2243610
- 3012307978
- 3008517911
- 3007165203
- 3007774468
- 3011545075
- 2438803
- 3011140418
- 9680411
- 3014889445
- 3007351543
- 3045892219
- 3042254864
- 1418300
- 9616441
- 3042228518
- 3026654653
- 8021087
- 3011191563
- 3010487482
- 3004378828
- 3009765418
- 3007930715
- 3004786168
- 3009515549
- 3031595774
- 1293762
- 3031182017
- 8022547
- 3013199482
- 3017160888
- 3013510936
- 3013544591
- 3005290074
- 3014273526
- 3042284339
- 3012978407
- 9710499
- 3027321376
- 3010889811
- 3006975595
- 1000481099
- 3026885374
- 3004167027
- 3014115331
- 3027395630
- 3021314602
- 3038220293
- 3012241679
- 3001033549
- 3006942545
- 3009455348
- 3012980312
- 3030319459
- 3010229247
- 1000387127
- 3024987631
- 2031962
- 9615180
- 9615448
- 3017884478
- 3030090215
- 3012483227
- 3014320483
- 3009275598
- 3014888885
- 3007607674
- 3011016506
- 3007065619
- 3014326379
- 3013150102
- 3015167910
- 3006532764
- 3031606441
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#
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FDA Review#
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