The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hydrocolloid Dressing For Psoriasis.
Device ID | K881039 |
510k Number | K881039 |
Device Name: | HYDROCOLLOID DRESSING FOR PSORIASIS |
Classification | Dressing, Wound, Drug |
Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Contact | Jerome A Saxon |
Correspondent | Jerome A Saxon HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-11 |
Decision Date | 1988-06-22 |