The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Incare Hot/ice Absorbent Interface.
| Device ID | K913035 |
| 510k Number | K913035 |
| Device Name: | INCARE HOT/ICE ABSORBENT INTERFACE |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| 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 | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-09 |
| Decision Date | 1991-09-25 |