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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K022406
Device Name EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET
Applicant
EXELINT INTL. CO.
5840 WEST CENTINELA AVE.
LOS ANGELES,  CA  90045
Applicant Contact ARMAND HAMID
Correspondent
EXELINT INTL. CO.
5840 WEST CENTINELA AVE.
LOS ANGELES,  CA  90045
Correspondent Contact ARMAND HAMID
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/23/2002
Decision Date 09/30/2002
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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