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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K052330
Device Name TRU-SWAB STOCOCK
Applicant
Medegen Medical Manufacturing Services
930 Wanamaker Ave.
Ontario,  CA  91761
Applicant Contact TIM 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
FMG  
Date Received08/26/2005
Decision Date 09/09/2005
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
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