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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, headband, surgical
510(k) Number K994362
Device Name HEADLAMP HL2000.
Applicant
ANGIOLAZ, INC.
P.O. BOX 556
INDUSTRIAL PARK
BELLOWS FALLS,  VT  05101
Applicant Contact ROBERT ALLMAN
Correspondent
ANGIOLAZ, INC.
P.O. BOX 556
INDUSTRIAL PARK
BELLOWS FALLS,  VT  05101
Correspondent Contact ROBERT ALLMAN
Regulation Number886.4335
Classification Product Code
FSR  
Date Received12/27/1999
Decision Date 05/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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