The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for Cook County Hospital Dressing Change Set.
| Device ID | K843206 |
| 510k Number | K843206 |
| Device Name: | COOK COUNTY HOSPITAL DRESSING CHANGE SET |
| Classification | Dressing, Wound, Drug |
| Applicant | GENEVA LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 | 1984-08-15 |
| Decision Date | 1985-05-24 |