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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 K895711
Device Name ACUFEX INTERFERENCE SCREW, STERILE
Applicant
Acufex Microsurgical, Inc.
575 University Ave.
Norwood,  MA  02062
Applicant Contact RICHARD E FRANKO
Correspondent
Acufex Microsurgical, Inc.
575 University Ave.
Norwood,  MA  02062
Correspondent Contact RICHARD E FRANKO
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/25/1989
Decision Date 01/09/1990
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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