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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 K935608
Device Name MAMOSPAT
Applicant
E.V.S. Tool & Die Co., Inc.
P.O. Box 191
Harrisville,  RI  02830
Applicant Contact JOYCE R SERAFIN
Correspondent
E.V.S. Tool & Die Co., Inc.
P.O. Box 191
Harrisville,  RI  02830
Correspondent Contact JOYCE R SERAFIN
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/19/1993
Decision Date 05/17/1994
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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