510(k) K790929
K790929 is an FDA 510(k) premarket notification submitted by Mem Medical, Inc. for the device "DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on May 21, 1979. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995. Mem Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1979
- Date Received
- May 15, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drain, Tee (Water Trap)
- Device Class
- Class I
- Regulation Number
- 868.5995
- Review Panel
- AN
- Submission Type