K851312Substantially Equivalent

Abco Isolation Masks

Name: K851312 Abco Isolation Masks
Creator: Abco Dealers, Inc.
Published: 1985-05-01
License: https://open.fda.gov/license/

Abco Dealers, Inc., Milwaukee WI / Traditional, Substantially Equivalent

FDA source

K851312 is the FDA 510(k) clearance record for ABCO ISOLATION MASKS, cleared for Abco Dealers, Inc. on 1985-05-01. FDA records list 127 510(k) clearances for Abco Dealers, Inc., from 1976-10-05 to 1991-02-07. As of 2026-09-10, FDA records show no recalls naming K851312.

Clearance record

Decision date: 1985-05-01
Received: 1985-04-02 (29 days to decision)
Review panel: Unknown
Applicant: Abco Dealers, Inc. P.O. Box 17587, Milwaukee WI
Third party review: No