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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Surgical
510(k) Number K926036
Device Name ACUFEX SUTURE RETRIEVER
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 Number878.4800
Classification Product Code
GAE  
Date Received12/01/1992
Decision Date 05/05/1993
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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