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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K855031
Device Name MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P
Applicant
Advanced Biosearch Assn.
1700 Rockville Pike
Suite 320
Rockville,  MD  20852
Applicant Contact JOEL S FADEN
Correspondent
Advanced Biosearch Assn.
1700 Rockville Pike
Suite 320
Rockville,  MD  20852
Correspondent Contact JOEL S FADEN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/16/1985
Decision Date 01/21/1986
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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