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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 K902001
Device Name SURGICAL RETENTION BAR
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 Received05/02/1990
Decision Date 05/09/1990
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
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