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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K020189
Device Name EXEL BUTTERFLY SCALP VEIN SET
Applicant
Exelint International, Co.
5840 W. Centinela Ave.
Los Angeles,  CA  90231 -3194
Applicant Contact TAMMIE EWING
Correspondent
Exelint International, Co.
5840 W. Centinela Ave.
Los Angeles,  CA  90231 -3194
Correspondent Contact TAMMIE EWING
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/18/2002
Decision Date 03/27/2003
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
Predetermined Change
Control Plan Authorized		 No
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