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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 K160610
Device Name Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set
Applicant
Kobold, LLC
P.O. Box 1994
Veradale,  WA  99037
Applicant Contact Brian Stoddart
Correspondent
Bb Medical Surgical, Inc.
1736 Stockton St.
San Francisco,  CA  94133
Correspondent Contact Christina Bernstein
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received03/03/2016
Decision Date 02/13/2017
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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