SHEATHS FOR REINFORCING BONE CEMENT
FDA 510(k) clearance K834499 · decided 1984-04-24
Clearance details
- K-number
- K834499
- Device name
- SHEATHS FOR REINFORCING BONE CEMENT
- Applicant
- Mecron Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-20
- Decision date
- 1984-04-24
- Days to decision
- 126 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.