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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K861279
Device Name FLUORO PLUS
Applicant
Advantage Medical Systems, Inc.
306 Main St.
Millburn,  NJ  07041
Applicant Contact ROBERT FOLLMER
Correspondent
Advantage Medical Systems, Inc.
306 Main St.
Millburn,  NJ  07041
Correspondent Contact ROBERT FOLLMER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/07/1986
Decision Date 06/16/1986
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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