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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K011575
Device Name 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022
Applicant
Imagyn Surgical
8850 M-89
P.O. Box 351
Richland,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
Imagyn Surgical
8850 M-89
P.O. Box 351
Richland,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number876.1075
Classification Product Code
KNW  
Date Received05/22/2001
Decision Date 08/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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