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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauge, Depth
510(k) Number K925335
Device Name ACUFEX INTRA ARTICULAR MEASURING DEVICE
Applicant
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact LLYNNE ARONSON
Correspondent
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact LLYNNE ARONSON
Regulation Number888.4300
Classification Product Code
HTJ  
Date Received10/22/1992
Decision Date 12/29/1992
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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