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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 K860152
Device Name MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY
Applicant
Endo Lase, Inc.
Attn: Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20006
Applicant Contact & HARTSON
Correspondent
Endo Lase, Inc.
Attn: Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20006
Correspondent Contact & HARTSON
Regulation Number878.4810
Classification Product Code
LNK  
Date Received01/15/1986
Decision Date 02/05/1986
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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