MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)

Catheter, Urological

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

The following data is part of a premarket notification filed by Medical Technologies Of Georgia, Inc. with the FDA for Mtg Instant Cather (with And Without Kit), Mtg Instant Cath Deluxe (with And Without Kit).

Pre-market Notification Details

• Device ID: K080878
• 510k Number: K080878
• Device Name: MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
• Classification: Catheter, Urological
• Applicant: MEDICAL TECHNOLOGIES OF GEORGIA, INC. 15151 PRATER DRIVE SUITE E Covington, GA 30014
• Contact: Cindi Sartain
• Correspondent: Cindi Sartain; MEDICAL TECHNOLOGIES OF GEORGIA, INC. 15151 PRATER DRIVE SUITE E Covington, GA 30014
• Product Code: KOD
• CFR Regulation Number: 876.5130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2008-03-31
• Decision Date: 2008-07-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50850025153183	K080878	000
50850025153602	K080878	000
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