The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Wound Care Barrier.
| Device ID | K862572 |
| 510k Number | K862572 |
| Device Name: | HOLLISTER WOUND CARE BARRIER |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-07 |
| Decision Date | 1986-08-04 |