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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, neurosurgical
510(k) Number K853580
Device Name MEDILAS 2
Applicant
ENDO LASE, INC.
ATTN: JONATHAN S. KAHAN
815 CONNECTICUT AVENUE
WASHINGTON,  DC  20006
Applicant Contact JONATHAN S KAHAN
Correspondent
ENDO LASE, INC.
ATTN: JONATHAN S. KAHAN
815 CONNECTICUT AVENUE
WASHINGTON,  DC  20006
Correspondent Contact JONATHAN S KAHAN
Classification Product Code
LKW  
Date Received08/26/1985
Decision Date 02/13/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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