ANSPAHC SPEED REDUCER
FDA 510(k) clearance K960630 · decided 1996-11-19
Clearance details
- K-number
- K960630
- Device name
- ANSPAHC SPEED REDUCER
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-02-09
- Decision date
- 1996-11-19
- Days to decision
- 284 days
- Clearance type
- Traditional
- Product code
- HBB
- Device class
- 2
- Regulation number
- 882.4370
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device i recall (Z-1900-2014) | The Anspach Effort, Inc. | 2014-06-25 |
| ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to b recall (Z-1901-2014) | The Anspach Effort, Inc. | 2014-06-25 |