510(k) K791908
K791908 is an FDA 510(k) premarket notification submitted by Mem Medical, Inc. for the device "RETARD VALVE 3-STACK #M-514". The FDA issued a decision of Substantially Equivalent on October 9, 1979. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Mem Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1979
- Date Received
- September 25, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Valve, Non-Rebreathing
- Device Class
- Class II
- Regulation Number
- 868.5870
- Review Panel
- AN
- Submission Type