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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 K161445
Device Name PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
Applicant
Adapta Medical, Inc.
142 Talamine Ct.
Colorado Springs,  CO  80907
Applicant Contact Adrian Elfe
Correspondent
Neil Burris & Associates
4250 Grove St.
Denver,  CO  80211
Correspondent Contact Neil Burris
Regulation Number876.5130
Classification Product Code
EZD  
Date Received05/25/2016
Decision Date 08/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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