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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 K884107
Device Name STEREOTACTIC BIOPSY ATTACHMENT
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact HARRY K SCHWILL
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact HARRY K SCHWILL
Regulation Number892.1710
Classification Product Code
IZH  
Date Received09/29/1988
Decision Date 05/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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