The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Restore Wound Cleanser.
| Device ID | K040779 |
| 510k Number | K040779 |
| Device Name: | RESTORE WOUND CLEANSER |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-26 |
| Decision Date | 2004-05-17 |
| Summary: | summary |