MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
FDA 510(k) clearance K844597 · decided 1985-04-08
Clearance details
- K-number
- K844597
- Device name
- MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
- Applicant
- Xanmed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-26
- Decision date
- 1985-04-08
- Days to decision
- 133 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.