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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K071382
Device Name SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,
Applicant
SHIN CHANG MEDICAL CO., LTD.
3762 SOUTH 150 EAST
salt lake city,  UT  84115
Applicant Contact jan j frank
Correspondent
SHIN CHANG MEDICAL CO., LTD.
3762 SOUTH 150 EAST
salt lake city,  UT  84115
Correspondent Contact jan j frank
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/17/2007
Decision Date 10/16/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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