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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 K083472
Device Name MEDEGEN PRESSURE RATED EXTENSION SETS
Applicant
Medegen, Inc.
930 Wanamaker Ave.
Ontario,  CA  91761 -8151
Applicant Contact TIM L TRUITT
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/24/2008
Decision Date 12/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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