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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 K933868
Device Name ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
Applicant
ANGIOLAZ, INC.
P.O. BOX 556
INDUSTRIAL PARK
BELLOWS FALLS,  VT  05101
Applicant Contact JOHN D PLUMADORE
Correspondent
ANGIOLAZ, INC.
P.O. BOX 556
INDUSTRIAL PARK
BELLOWS FALLS,  VT  05101
Correspondent Contact JOHN D PLUMADORE
Regulation Number876.1500
Classification Product Code
GCT  
Date Received08/06/1993
Decision Date 11/10/1993
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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