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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K030715
Device Name SAFFRON NM GUIDING CATHETER
Applicant
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
1 JINKUI ROAD, FUTIAN FREE
TRADE ZONE
SHENZHEN, GUANGDONG,  CN 518038
Applicant Contact RAYMOND LIN
Correspondent
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
1 JINKUI ROAD, FUTIAN FREE
TRADE ZONE
SHENZHEN, GUANGDONG,  CN 518038
Correspondent Contact RAYMOND LIN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/07/2003
Decision Date 04/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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