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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Surgical, Gynecologic
510(k) Number K853903
Device Name ENDO-LASE CD40 CO2 FOR GYNECOLOGY
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
Regulation Number884.4550
Classification Product Code
HHR  
Date Received09/20/1985
Decision Date 02/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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