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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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