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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K951326
Device Name BIOPSY DEVICE ACCESSORY
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 Number878.4780
Classification Product Code
BTA  
Date Received03/23/1995
Decision Date 05/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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