EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153
FDA 510(k) clearance K851207 · decided 1985-04-08
Clearance details
- K-number
- K851207
- Device name
- EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153
- Applicant
- Travenol Laboratories, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-26
- Decision date
- 1985-04-08
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- KDJ
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Deerfield, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.