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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Orthopedic
510(k) Number K933921
Device Name ACUFLEX DISPOSABLE KNIVES
Applicant
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact LYNNE ARONSON
Correspondent
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact LYNNE ARONSON
Regulation Number888.4540
Classification Product Code
HTS  
Date Received08/10/1993
Decision Date 01/26/1994
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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