The following data is part of a premarket notification filed by Molnlycke Health Care, Inc. with the FDA for Alldress, Absorbent Film Dressing.
| Device ID | K983554 |
| 510k Number | K983554 |
| Device Name: | ALLDRESS, ABSORBENT FILM DRESSING |
| Classification | Bandage, Liquid |
| Applicant | MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone, PA 19022 |
| Contact | Miguel A Negron |
| Correspondent | Miguel A Negron MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone, PA 19022 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1998-11-10 |
| Summary: | summary |