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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prostate Immobilizer Rectal Balloon
510(k) Number K141958
Device Name ERB ENDORECTAL BALLOON
Applicant
Edge Medical, LLC
3924 Cascade Beach Rd.
Lutsen,  MN  55612
Applicant Contact GREGORY MATHISON
Correspondent
Edge Medical, LLC
3924 Cascade Beach Rd.
Lutsen,  MN  55612
Correspondent Contact GREGORY MATHISON
Regulation Number892.5720
Classification Product Code
PCT  
Date Received07/18/2014
Decision Date 11/18/2014
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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