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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 K921860
Device Name MODIFICATION TO IV SPIKE
Applicant
MCGAW, INC.
2525 MCGAW AVE.
P.O. BOX 19791
IRVINE,  CA  92713 -9791
Applicant Contact DIANE GERST
Correspondent
MCGAW, INC.
2525 MCGAW AVE.
P.O. BOX 19791
IRVINE,  CA  92713 -9791
Correspondent Contact DIANE GERST
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/11/1992
Decision Date 07/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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