BARRIER GOWN, KOOL-GARD BACKLESS GOWN— 510(k) K952115

Substantially Equivalent

American Threshold Industries, Inc.

FDA 510(k) clearance K952115 for BARRIER GOWN, KOOL-GARD BACKLESS GOWN, Substantially Equivalent on 1995-09-25. Applicant: American Threshold Industries, Inc..

Clearance details

Applicant
American Threshold Industries, Inc.
Product code
Code FYC
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Enka, NC, US
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