HYDROFLEX

Material, Impression

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Hydroflex.

Pre-market Notification Details

• Device ID: K970656
• 510k Number: K970656
• Device Name: HYDROFLEX
• Classification: Material, Impression
• Applicant: GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803
• Contact: Terry L Joritz
• Correspondent: Terry L Joritz; GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-02-21
• Decision Date: 1997-04-08