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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K954734
Device Name THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
Applicant
THE TULIP MFG. CO.
40 WEST BASELINE RD.,
SUITE 120
MESA,  AZ  85210
Applicant Contact RICHARD S HUNTER
Correspondent
THE TULIP MFG. CO.
40 WEST BASELINE RD.,
SUITE 120
MESA,  AZ  85210
Correspondent Contact RICHARD S HUNTER
Regulation Number876.1500
Classification Product Code
FET  
Date Received10/03/1995
Decision Date 11/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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