K821395Substantially Equivalent

Saddlebag Instrument Pad W/pouches

Name: K821395 Saddlebag Instrument Pad W/pouches
Creator: Kleen Test Products
Published: 1982-06-03
License: https://open.fda.gov/license/

Kleen Test Products Corporation, Mchenry IL / Traditional, Substantially Equivalent

FDA source

K821395 is the FDA 510(k) clearance record for SADDLEBAG INSTRUMENT PAD W/POUCHES, cleared for Kleen Test Products on 1982-06-03. FDA records list 17 510(k) clearances for Kleen Test Products, from 1976-11-02 to 1989-10-24. As of 2026-09-10, FDA records show no recalls naming K821395.

Clearance record

Decision date: 1982-06-03
Received: 1982-05-11 (23 days to decision)
Review panel: Unknown
Applicant: Kleen Test Products 803 N. Front St. Suite 3, Mchenry IL
Third party review: No