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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 K970642
Device Name TENOSCOPE
Applicant
Luxtec Corp.
45 Pontiac Rd.
Newton,  MA  02168
Applicant Contact JOSEPH RESS
Correspondent
Luxtec Corp.
45 Pontiac Rd.
Newton,  MA  02168
Correspondent Contact JOSEPH RESS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/20/1997
Decision Date 05/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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