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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K933948
Device Name ACUFEX ENDOBUTTON SYSTEM
Applicant
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact FREDERICK TOBIA
Correspondent
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact FREDERICK TOBIA
Regulation Number888.3030
Classification Product Code
MAI  
Date Received08/12/1993
Decision Date 07/21/1994
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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