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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, Manual
510(k) Number K010166
Device Name IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
Applicant
Imagyn Medical Technologies, Inc.
8850 M-89
Richland,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
Imagyn Medical Technologies, Inc.
8850 M-89
Richland,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received01/18/2001
Decision Date 12/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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