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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K131072
Device Name ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
Applicant
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact BRIAN SCHMIDT
Correspondent
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact BRIAN SCHMIDT
Regulation Number876.1500
Classification Product Code
OCY  
Date Received04/17/2013
Decision Date 07/09/2013
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
Predetermined Change
Control Plan Authorized		 No
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