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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, General & Plastic Surgery
510(k) Number K953962
Device Name FORCEPS
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 Number878.4800
Classification Product Code
GEN  
Date Received08/22/1995
Decision Date 09/08/1995
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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