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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 K882133
Device Name MAMMO M
Applicant
Ziehm International, Inc.
4181 Latham St.
Riverside,  CA  92501
Applicant Contact WOLFRAM H KLAWITTER
Correspondent
Ziehm International, Inc.
4181 Latham St.
Riverside,  CA  92501
Correspondent Contact WOLFRAM H KLAWITTER
Regulation Number892.1710
Classification Product Code
IZH  
Date Received05/20/1988
Decision Date 09/19/1988
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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