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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K133922
Device Name GENTLECARE AR APPLICATOR
Applicant
Gc Medtech, LLC
3924 Cascade Beach Rd.
Lutsen,  MN  55612
Applicant Contact GREGORY MATHISON
Correspondent
Gc Medtech, LLC
3924 Cascade Beach Rd.
Lutsen,  MN  55612
Correspondent Contact GREGORY MATHISON
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received12/23/2013
Decision Date 04/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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