510(k) K792113
K792113 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR MANOMETER CONNECTORS". The FDA issued a decision of Substantially Equivalent on Dec 5, 1979. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 5, 1979
- Date Received
- Oct 25, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4290
- Review Panel
- CV
- Submission Type
- 510(k) Exempt