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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 K922391
Device Name ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS
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 Received05/20/1992
Decision Date 08/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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