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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light, surgical, floor standing
510(k) Number K981821
Device Name VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
Applicant
ANGIOLAZ, INC.
INDUSTRIAL PARK
BELLOWS FALLS,  VT  05101 -0556
Applicant Contact JOHN D PLUMADORE
Correspondent
ANGIOLAZ, INC.
INDUSTRIAL PARK
BELLOWS FALLS,  VT  05101 -0556
Correspondent Contact JOHN D PLUMADORE
Regulation Number878.4580
Classification Product Code
FSS  
Date Received05/22/1998
Decision Date 07/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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