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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 K973148
Device Name MACOM
Applicant
A.Stein - Regulatory Affairs Consulting
P.O.B. 454
Ginot Shomron 44853,  IL 44853
Applicant Contact AHAVA STEIN
Correspondent
A.Stein - Regulatory Affairs Consulting
P.O.B. 454
Ginot Shomron 44853,  IL 44853
Correspondent Contact AHAVA STEIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/22/1997
Decision Date 11/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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