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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K020964
Device Name NEICH NM ADVANCE CATHETER SHEATH INTRODUCER
Applicant
Neich Medical(Shenzhen)Company, Ltd.
#1 Jinkui Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Applicant Contact HUANG JIN
Correspondent
Neich Medical(Shenzhen)Company, Ltd.
#1 Jinkui Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Correspondent Contact HUANG JIN
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/25/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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