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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 K931621
FOIA Releasable 510(k) K931621
Device Name ACUFEX PRO-PAC AND ISO-PAC
Applicant
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact FREDERICK TOBIA
Correspondent
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact FREDERICK TOBIA
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/02/1993
Decision Date 01/21/1994
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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