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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 K922557
Device Name ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT
Applicant
ACUFEX MICROSURGICAL, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact JEFFREY HENDERSON
Correspondent
ACUFEX MICROSURGICAL, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact JEFFREY HENDERSON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/29/1992
Decision Date 09/17/1992
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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