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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 K940230
Device Name ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS
Applicant
INSTRATEK, INC.
11210 STEEPLECREST
SUITE 130
HOUSTON,  TX  77065
Applicant Contact PERRY C FORRESTER
Correspondent
INSTRATEK, INC.
11210 STEEPLECREST
SUITE 130
HOUSTON,  TX  77065
Correspondent Contact PERRY C FORRESTER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/14/1994
Decision Date 12/12/1994
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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