The following data is part of a premarket notification filed by Scott Health Care with the FDA for Alldress Multi Layered Wound Dressing.
| Device ID | K910857 |
| 510k Number | K910857 |
| Device Name: | ALLDRESS MULTI LAYERED WOUND DRESSING |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | SCOTT HEALTH CARE SCOTT PLAZA III Philadelphia, PA 19113 -1585 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer SCOTT HEALTH CARE SCOTT PLAZA III Philadelphia, PA 19113 -1585 |
| 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 | 1991-02-28 |
| Decision Date | 1991-04-12 |