SPIRIT SHIELD
FDA 510(k) clearance K931718 · decided 1993-09-20
Clearance details
- K-number
- K931718
- Device name
- SPIRIT SHIELD
- Applicant
- Eaton Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-06
- Decision date
- 1993-09-20
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- HQY
- Device class
- 1
- Regulation number
- 886.5850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Eaton Medical Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| EASY EYES (TM) (P830009/S008) | Eaton Medical Corp. | 1988-03-23 |
| EASY EYES (TM) (P830009/S007) | Eaton Medical Corp. | 1985-04-23 |
| EASY EYES (TM) (P830009/S006) | Eaton Medical Corp. | 1985-04-23 |
| EASY EYES (TM) (P830009/S004) | Eaton Medical Corp. | 1984-08-10 |
| EASY EYES (TM) (P830009/S003) | Eaton Medical Corp. | 1984-05-15 |
| EASY EYES (TM) (P830009/S005) | Eaton Medical Corp. | 1984-03-15 |
| EASY EYES (TM) (P830009/S001) | Eaton Medical Corp. | 1984-02-08 |
| EASY EYES (TM) (P830009/S002) | Eaton Medical Corp. | 1983-11-17 |