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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 K885183
Device Name ENDOSCOPIC LIGHT SOURCE
Applicant
Technology For Imaging, Inc.
200 Homer Ave.
Ashland,  MA  01721
Applicant Contact RICHARD SCHERMERHORN
Correspondent
Technology For Imaging, Inc.
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact RICHARD SCHERMERHORN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/13/1988
Decision Date 03/09/1989
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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