ANEUROPLASTIC, MODEL 43-1290
FDA 510(k) clearance K071776 · decided 2007-07-26
Clearance details
- K-number
- K071776
- Device name
- ANEUROPLASTIC, MODEL 43-1290
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-29
- Decision date
- 2007-07-26
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- JXH
- Device class
- 2
- Regulation number
- 882.5030
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Raynham, MA, US
- 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 |
|---|---|---|
| ORTHOPAEDIC AND SPINAL RING CURRETTES (K882072) | Karlin Technology, Inc. | 1988-06-17 |
| ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL (K873688) | Dentsply Intl. | 1987-10-26 |
Recalls involving this device
No recalls on record reference this clearance.