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 | K945206 |
| 510k Number | K945206 |
| Device Name: | ALLDRESS MULTI LAYERED WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | SCOTT HEALTH CARE P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Larry Bogart |
| Correspondent | Larry Bogart SCOTT HEALTH CARE P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-25 |
| Decision Date | 1995-01-12 |