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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 WEST OLYMPIC BLVD.
WESTSIDE TOWERS SUITE 1000
LOS ANGELES,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
INTL. MEDICAL DEVICES LTD.
11845 WEST 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
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