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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Endoscope, Xenon Arc
510(k) Number K952563
Device Name THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM
Applicant
THE TULIP MFG. CO.
40 WEST BASELINE RD.,
SUITE 120
MESA,  AZ  85210
Applicant Contact MARCILLE PILKINGTON
Correspondent
THE TULIP MFG. CO.
40 WEST BASELINE RD.,
SUITE 120
MESA,  AZ  85210
Correspondent Contact MARCILLE PILKINGTON
Regulation Number876.1500
Classification Product Code
GCT  
Subsequent Product Code
FEM  
Date Received06/02/1995
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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