REUSABLE DEXTRA SYNOVIAL RESECTORS IN 3.5/4.5/5.5M
FDA 510(k) clearance K853491 · decided 1985-09-06
Clearance details
- K-number
- K853491
- Device name
- REUSABLE DEXTRA SYNOVIAL RESECTORS IN 3.5/4.5/5.5M
- Applicant
- Chattanooga Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-20
- Decision date
- 1985-09-06
- Days to decision
- 17 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Red Bank, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.