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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retention Device, Suture
510(k) Number K896310
Device Name ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE
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 Number878.4930
Classification Product Code
KGS  
Date Received11/01/1989
Decision Date 11/20/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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