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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Surgical And Accessories
510(k) Number K863800
Device Name ENDOSCOPIC VIDEO CAMERA
Applicant
Technology For Imaging, Inc.
24 Parker Rd.
Framingham,  MA  01701
Applicant Contact RICHARD SCHERMERHORN
Correspondent
Technology For Imaging, Inc.
24 Parker Rd.
Framingham,  MA  01701
Correspondent Contact RICHARD SCHERMERHORN
Regulation Number878.4160
Classification Product Code
KQM  
Date Received09/29/1986
Decision Date 10/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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