HYDROFLEX— 510(k) K970656

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K970656 for HYDROFLEX, Substantially Equivalent on 1997-04-08. Applicant: GC America, Inc..

Clearance details

Applicant: GC America, Inc.
Product code: Code ELW
Advisory panel: Dental
Date received: 1997-02-21
Decision date: 1997-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

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