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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 K982049
Device Name BIOPSY M
Applicant
Sitco, Inc.
3456 N. Ridge Ave. #100
Arlington Heights,  IL  60004
Applicant Contact ROBERT H MCCARTHY
Correspondent
Sitco, Inc.
3456 N. Ridge Ave. #100
Arlington Heights,  IL  60004
Correspondent Contact ROBERT H MCCARTHY
Regulation Number892.1710
Classification Product Code
IZH  
Date Received06/11/1998
Decision Date 07/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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