The following data is part of a premarket notification filed by Mem Medical, Inc. with the FDA for Drainage Bag.
Device ID | K790929 |
510k Number | K790929 |
Device Name: | DRAINAGE BAG |
Classification | Drain, Tee (water Trap) |
Applicant | MEM MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BYH |
CFR Regulation Number | 868.5995 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-15 |
Decision Date | 1979-05-21 |