The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Drainage Bag.
| Device ID | K990428 |
| 510k Number | K990428 |
| Device Name: | DRAINAGE BAG |
| Classification | Bag, Bile Collecting |
| Applicant | REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta, GA 30005 |
| Contact | Steve Woody |
| Correspondent | Steve Woody REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta, GA 30005 |
| Product Code | EXF |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-11 |
| Decision Date | 1999-08-12 |