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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K844460
Device Name ND. YAG LASER RECTAL PATHOLOGY
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 Number878.4810
Classification Product Code
LNK  
Date Received11/15/1984
Decision Date 01/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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