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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 K843628
Device Name HOTIP HEMOSTATIC PROBE
Applicant
Trimedyne, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Trimedyne, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4810
Classification Product Code
LNK  
Date Received09/14/1984
Decision Date 11/12/1985
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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