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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tap, Bone
510(k) Number K873067
Device Name ACROMED BONE SCREW TAP SLEEVES
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 Number888.4540
Classification Product Code
HWX  
Date Received08/05/1987
Decision Date 09/02/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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