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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Catheter
510(k) Number K913543
Device Name THORACIC CATHETER STYLET
Applicant
Intl. Medical Devices , Ltd.
11845 W. Olympic Blvd.
Westside Towers Suite 1000
Los Angeles,  CA  90064
Applicant Contact JAY GELLER
Correspondent
Intl. Medical Devices , Ltd.
11845 W. Olympic Blvd.
Westside Towers Suite 1000
Los Angeles,  CA  90064
Correspondent Contact JAY GELLER
Regulation Number870.1380
Classification Product Code
DRB  
Date Received08/09/1991
Decision Date 10/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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