CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)
FDA 510(k) clearance K861198 · decided 1986-05-16
Clearance details
- K-number
- K861198
- Device name
- CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)
- Applicant
- Quali-Med, Inc.
- Decision
- Unknown
- Date received
- 1986-03-31
- Decision date
- 1986-05-16
- Days to decision
- 46 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Sugar Land, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.