510(k) K791851
K791851 is an FDA 510(k) premarket notification submitted by Mem Medical, Inc. for the device "RED CAP, M-502". The FDA issued a decision of Substantially Equivalent on October 1, 1979. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Mem Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 1979
- Date Received
- September 19, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Pressure And Accessories
- Device Class
- Class I
- Regulation Number
- 868.5860
- Review Panel
- AN
- Submission Type