K853558Substantially Equivalent

Dosimetric Release/radiation Steriliz. Absorb Gauz

Name: K853558 Dosimetric Release/radiation Steriliz. Absorb Gauz
Creator: American White Cross, Inc.
Published: 1985-09-05
License: https://open.fda.gov/license/

American White Cross, Inc., Stamford CT / Traditional, Substantially Equivalent

FDA source

K853558 is the FDA 510(k) clearance record for DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ, cleared for American White Cross, Inc. on 1985-09-05. FDA records list 10 510(k) clearances for American White Cross, Inc., from 1985-03-11 to 1997-02-06. As of 2026-09-10, FDA records show no recalls naming K853558.

Clearance record

Decision date: 1985-09-05
Received: 1985-08-26 (10 days to decision)
Review panel: Unknown
Applicant: American White Cross, Inc. 56 Westcott Rd., Stamford CT
Third party review: No