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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 K951229
Device Name MODIFIED BIOPSY NEEDLE
Applicant
BIOPSYS MEDICAL, INC.
27130 A PASEO ESPADA,
SUITE 1424
SAN JUAN CAPISTRANO,  CA  92675
Applicant Contact MARK A COLE
Correspondent
BIOPSYS MEDICAL, INC.
27130 A PASEO ESPADA,
SUITE 1424
SAN JUAN CAPISTRANO,  CA  92675
Correspondent Contact MARK A COLE
Regulation Number876.1075
Classification Product Code
KNW  
Date Received03/20/1995
Decision Date 04/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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