The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Elastoplast Heat Plaster.
| Device ID | K925630 |
| 510k Number | K925630 |
| Device Name: | ELASTOPLAST HEAT PLASTER |
| Classification | Pad, Medicated, Adhesive, Non-electric |
| Applicant | BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Product Code | MLX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-06 |
| Decision Date | 1994-02-25 |