The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Simplicare Thin Film Wound Dressings.
| Device ID | K980209 |
| 510k Number | K980209 |
| Device Name: | SIMPLICARE THIN FILM WOUND DRESSINGS |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joseph S Tokarz |
| Correspondent | Joseph S Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-20 |
| Decision Date | 1998-02-20 |
| Summary: | summary |