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


Device Classification Name

catheter, urological

510(k) Number K080878
Device Name MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
Applicant
MEDICAL TECHNOLOGIES OF GEORGIA, INC.
15151 prater drive
suite e
covington, 
GA 
30014

Applicant Contact cindi sartain
Correspondent
MEDICAL TECHNOLOGIES OF GEORGIA, INC.
15151 prater drive
suite e
covington, 
GA 
30014

Correspodent Contact cindi sartain
Regulation Number 876.5130
Classification Product Code
KOD  
Date Received 03/31/2008
Decision Date 07/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes