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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 K921390
Device Name XENON LIGHT SOURCE AND ACCESSORIES
Applicant
Coopervision Surgical
15 Forest Pkwy.
Shelton,  CT  06484
Applicant Contact CLIFFORD F POTOCKY
Correspondent
Coopervision Surgical
15 Forest Pkwy.
Shelton,  CT  06484
Correspondent Contact CLIFFORD F POTOCKY
Regulation Number876.1500
Classification Product Code
GCT  
Date Received03/23/1992
Decision Date 07/27/1992
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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