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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 K051499
Device Name INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
Applicant
MEDEGEN MEDICAL MANUFACTURING SERVICES
15 CHEROKEE
TRABUCO CANYON,  CA  92679
Applicant Contact SALVADORE F PALOMARES
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/07/2005
Decision Date 06/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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