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,

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

Correspodent Contact jan j frank
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 05/17/2007
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