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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 K871048
Device Name MICRO MAMMO I MAMMOGRAPHY UNIT
Applicant
Amerasia Import-Export, Inc.
1400 E. 7th St.
Reno,  NV  89512
Applicant Contact ARTHUR WATTS
Correspondent
Amerasia Import-Export, Inc.
1400 E. 7th St.
Reno,  NV  89512
Correspondent Contact ARTHUR WATTS
Regulation Number892.1710
Classification Product Code
IZH  
Date Received03/17/1987
Decision Date 09/01/1987
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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