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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K010412
Device Name FLEXIBLE ENDOSCOPIC SCISSORS
Applicant
Telemed Systems, Inc.
8 Kane Industrial Dr.
Hudson,  MA  01749
Applicant Contact MICHAEL CARROLL
Correspondent
Telemed Systems, Inc.
8 Kane Industrial Dr.
Hudson,  MA  01749
Correspondent Contact MICHAEL CARROLL
Regulation Number876.1500
Classification Product Code
OCZ  
Date Received02/12/2001
Decision Date 04/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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