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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, Fiberoptic, Routine
510(k) Number K964586
Device Name PRESCOTT'S LIGHT SOURCE MODEL NO. II-150
Applicant
IBA/GRIFFITH
P.O. BOX 609
MONUMENT,  CO  80132 -0609
Applicant Contact PAUL C REDNER
Correspondent
IBA/GRIFFITH
P.O. BOX 609
MONUMENT,  CO  80132 -0609
Correspondent Contact PAUL C REDNER
Regulation Number876.1500
Classification Product Code
FCW  
Date Received11/15/1996
Decision Date 01/17/1997
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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