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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neodymium:Yag, Pulmonary Surgery
510(k) Number K852507
Device Name ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION
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
LLO  
Date Received06/12/1985
Decision Date 07/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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