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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 K925083
Device Name ENDOTRAK SYSTEM
Applicant
Instratek, Inc.
11210 Steeplecrest
Suite 130
Houston,  TX  77065
Applicant Contact PERRY FORRESTER
Correspondent
Instratek, Inc.
11210 Steeplecrest
Suite 130
Houston,  TX  77065
Correspondent Contact PERRY FORRESTER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/07/1992
Decision Date 04/27/1993
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
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