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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K925573
Device Name ACUFEX T-BAR
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 Number888.1100
Classification Product Code
HRX  
Date Received11/03/1992
Decision Date 05/05/1993
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
Recalls CDRH Recalls
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