MEDCOMP DISPOSABLE MANIFOLD SYSTEM
FDA 510(k) clearance K863661 · decided 1986-09-29
Clearance details
- K-number
- K863661
- Device name
- MEDCOMP DISPOSABLE MANIFOLD SYSTEM
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-18
- Decision date
- 1986-09-29
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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.