The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for Accupac Custom Pack Kerlix Squares.
| Device ID | K861308 |
| 510k Number | K861308 |
| Device Name: | ACCUPAC CUSTOM PACK KERLIX SQUARES |
| Classification | Gauze/sponge, Internal |
| Applicant | GENEVA LABORATORIES, INC. P.O. BOX 444 Elkhorn, WI 53121 |
| Contact | Gary L Swanson |
| Correspondent | Gary L Swanson GENEVA LABORATORIES, INC. P.O. BOX 444 Elkhorn, WI 53121 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-08 |
| Decision Date | 1986-05-02 |