The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Incare Pinsite Dressing.
| Device ID | K905206 |
| 510k Number | K905206 |
| Device Name: | INCARE PINSITE DRESSING |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Sharon A Leaf |
| Correspondent | Sharon A Leaf HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-04-12 |