SUNQUEST INTERNATIONAL
FDA 510(k) clearance K963059 · decided 1996-08-23
Clearance details
- K-number
- K963059
- Device name
- SUNQUEST INTERNATIONAL
- Applicant
- Sunquest Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-02
- Decision date
- 1996-08-23
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- HQY
- Device class
- 1
- Regulation number
- 886.5850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Taipei, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NON-PRESCRIPTION SUNGLASSES (K974860) | Wenzhou Ming Ming Optical Co. , Ltd. | 1998-01-30 |
| NON-PRESCRIPTION SUNGLASSES (K974852) | Chia Hui Spectacles Mfg. Corp. | 1998-01-30 |
| NON-PRESCRIPTION SUNGLASSES (K974861) | Wenzhou Hindar Optical Co., Ltd. | 1998-01-27 |
| SUNGLASSES (K974511) | Sun World Intl., Inc. | 1998-01-12 |
| SUNGLASSES (K974441) | Hip Shing Fat Co., Ltd. | 1998-01-09 |
| MULTI (K974414) | Morning Calm Corp. | 1997-12-08 |
| SUNGLASSES (K973528) | Jeou Jeou Long Industrial Co., Ltd. | 1997-12-08 |
| NON-PRESCRIPTION SUNGLASSES (K974179) | Taipan Optical Company , Ltd. | 1997-12-01 |
| VENNETO (K974045) | Amsure Sports, Inc. | 1997-11-20 |
| SUNGLASSES (K973934) | Elegance Optical Manufactory, Ltd. | 1997-11-18 |
| SUNGLASSES (K973526) | Pyramid Handbags, Inc. | 1997-10-16 |
| SUNGLASSES (K973490) | Tong Yang Optical Co. | 1997-09-30 |
Recalls involving this device
No recalls on record reference this clearance.