MEDCOMP PERITONEAL DIALYSIS CATHETERS
FDA 510(k) clearance K915490 · decided 1994-02-02
Clearance details
- K-number
- K915490
- Device name
- MEDCOMP PERITONEAL DIALYSIS CATHETERS
- Applicant
- Medical Components, Inc.
- Decision
- Unknown
- Date received
- 1991-12-06
- Decision date
- 1994-02-02
- Days to decision
- 789 days
- Clearance type
- Traditional
- Product code
- FJS
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.