The following data is part of a premarket notification filed by Mem Medical, Inc. with the FDA for Three Liter Bag #m-512.
| Device ID | K791910 |
| 510k Number | K791910 |
| Device Name: | THREE LITER BAG #M-512 |
| Classification | Bag, Reservoir |
| Applicant | MEM MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTC |
| CFR Regulation Number | 868.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-25 |
| Decision Date | 1979-10-09 |