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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K913539
Device Name THORACIC CATHTER STYLET
Applicant
Intl. Medical Devices , Ltd.
11845 W. Olympic Blvd.
Westside Towers Suite 1000
Los Angeles,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
Intl. Medical Devices , Ltd.
11845 W. Olympic Blvd.
Westside Towers Suite 1000
Los Angeles,  CA  90064
Correspondent Contact JAY H GELLER
Regulation Number878.4200
Classification Product Code
GBX  
Date Received08/09/1991
Decision Date 01/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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