The following data is part of a premarket notification filed by Molnlycke/scott Health Care with the FDA for Alldress Multi Layered Wound Dressing.
| Device ID | K955863 |
| 510k Number | K955863 |
| Device Name: | ALLDRESS MULTI LAYERED WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | MOLNLYCKE/SCOTT HEALTH CARE 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer MOLNLYCKE/SCOTT HEALTH CARE 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-27 |
| Decision Date | 1996-03-13 |
| Summary: | summary |