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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K913540
Device Name PEDIA-THOR THORACOSTOMY KIT
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 Number880.5860
Classification Product Code
FMF  
Date Received08/09/1991
Decision Date 04/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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