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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K936161
Device Name SYSTEM, X-RAY, MAMOGRAPHIC
Applicant
Technowipe
283 Murray Ave.
Larchmont,  NY  10538
Applicant Contact ELEANOR SHERMAN
Correspondent
Technowipe
283 Murray Ave.
Larchmont,  NY  10538
Correspondent Contact ELEANOR SHERMAN
Regulation Number892.1710
Classification Product Code
IZH  
Date Received12/27/1993
Decision Date 05/04/1994
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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