GC FUSION

Material, Impression

GC AMERICA, INC.

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

Pre-market Notification Details

• Device ID: K041398
• 510k Number: K041398
• Device Name: GC FUSION
• Classification: Material, Impression
• Applicant: GC AMERICA, INC. 3737 W. 127TH ST. Alsip, IL 60803
• Contact: Terry L Joritz
• Correspondent: Terry L Joritz; GC AMERICA, INC. 3737 W. 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: 2004-05-26
• Decision Date: 2004-06-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10386040001441	K041398	000
20386040005309	K041398	000
20386040005361	K041398	000
20386040005514	K041398	000
10386040005555	K041398	000
20386040005569	K041398	000
20386040005583	K041398	000
10386040005692	K041398	000
10386040005708	K041398	000
20386040005194	K041398	000
20386040005170	K041398	000
10386040001458	K041398	000
10386040001502	K041398	000
10386040001526	K041398	000
10386040001571	K041398	000
10386040001588	K041398	000
10386040001595	K041398	000
10386040001649	K041398	000
10386040001762	K041398	000
10386040005715	K041398	000
10386040005722	K041398	000
10386040005739	K041398	000
00386040006098	K041398	000
10386040006101	K041398	000
20386040013359	K041398	000
20386040013366	K041398	000
10386040013376	K041398	000
10386040013383	K041398	000
10386040013390	K041398	000
10386040013406	K041398	000
10386040005845	K041398	000
10386040005838	K041398	000
10386040005746	K041398	000
10386040005753	K041398	000
10386040005760	K041398	000
10386040005777	K041398	000
10386040005784	K041398	000
10386040005791	K041398	000
10386040005807	K041398	000
10386040005814	K041398	000
D6581378651	K041398	000