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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name guide, needle, surgical
510(k) Number K882036
Device Name WILLIAMS ACS MARKER NEEDLE
Applicant
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number878.4800
Classification Product Code
GDF  
Date Received05/16/1988
Decision Date 07/27/1988
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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