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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K103043
Device Name COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH
Applicant
ADAPTA MEDICAL, INC
4250 GROVE STREET
DENVER,  CO  80211
Applicant Contact NEIL BURRIS
Correspondent
ADAPTA MEDICAL, INC
4250 GROVE STREET
DENVER,  CO  80211
Correspondent Contact NEIL BURRIS
Regulation Number876.5130
Classification Product Code
EZD  
Date Received10/14/2010
Decision Date 01/07/2011
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 No
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