K853265Substantially Equivalent

Accupac Custom Operating Room Procedure-Dk876543

Name: K853265 Accupac Custom Operating Room Procedure-Dk876543
Creator: Geneva Laboratories, Inc.
Published: 1985-08-26
License: https://open.fda.gov/license/

Geneva Laboratories, Inc., Elkhorn WI / Traditional, Substantially Equivalent

FDA source

K853265 is the FDA 510(k) clearance record for ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543, cleared for Geneva Laboratories, Inc. on 1985-08-26. FDA records list 13 510(k) clearances for Geneva Laboratories, Inc., from 1981-01-15 to 1988-07-29. As of 2026-09-10, FDA records show no recalls naming K853265.

Clearance record

Decision date: 1985-08-26
Received: 1985-08-05 (21 days to decision)
Review panel: Unknown
Applicant: Geneva Laboratories, Inc. P.O. Box 444, Elkhorn WI
Third party review: No