The following data is part of a premarket notification filed by American Medical Disposable, Inc. with the FDA for Heavy Drainage Pack.
| Device ID | K803116 |
| 510k Number | K803116 |
| Device Name: | HEAVY DRAINAGE PACK |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | AMERICAN MEDICAL DISPOSABLE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-10 |
| Decision Date | 1981-01-28 |