The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Simplicare Transparent Wound Dressing.
| Device ID | K991214 |
| 510k Number | K991214 |
| Device Name: | SIMPLICARE TRANSPARENT WOUND DRESSING |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-09 |
| Decision Date | 1999-10-14 |
| Summary: | summary |