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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ent Microsurgical Carbon-Dioxide
510(k) Number K853902
Device Name ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
Applicant
Endo Lase, Inc.
Attn: Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20006
Applicant Contact JONATHAN S KAHAN
Correspondent
Endo Lase, Inc.
Attn: Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20006
Correspondent Contact JONATHAN S KAHAN
Regulation Number874.4500
Classification Product Code
EWG  
Date Received09/20/1985
Decision Date 01/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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