SHADOW MEDAL LOCATOR
FDA 510(k) clearance K953277 · decided 1996-04-01
Clearance details
- K-number
- K953277
- Device name
- SHADOW MEDAL LOCATOR
- Applicant
- Fatswith Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-13
- Decision date
- 1996-04-01
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- HPM
- Device class
- 2
- Regulation number
- 886.4400
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Vancouver, Bc,, CA
- 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 |
|---|---|---|
| PEDIATRIC INGESTASCAN (K003305) | Adams Electronics, Inc. | 2000-12-22 |
| PMT METAL LOCATOR, MODEL 3630-1 (K911886) | Pmt Corp. | 1991-08-12 |
| LOCATOR, FOREIGN BODY (K781892) | Keeler Optical Products , Ltd. | 1978-12-04 |
Recalls involving this device
No recalls on record reference this clearance.