K834539Substantially Equivalent

Axipac II

Name: K834539 Axipac II
Creator: Teknar, Inc.
Published: 1984-09-11
License: https://open.fda.gov/license/

Teknar, Inc., Walker MI / Traditional, Substantially Equivalent

FDA source

K834539 is the FDA 510(k) clearance record for AXIPAC II, cleared for Teknar, Inc. on 1984-09-11. FDA records list 18 510(k) clearances for Teknar, Inc., from 1980-09-09 to 1990-11-19. As of 2026-09-10, FDA records show no recalls naming K834539.

Clearance record

Decision date: 1984-09-11
Received: 1983-12-14 (272 days to decision)
Review panel: Unknown
Applicant: Teknar, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review: No