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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, irrigating (non dental)
510(k) Number K092022
Device Name TISSU TRANS HARVEST TUBING
Applicant
SHIPPERT MEDICAL TECHNOLOGIES CORP.
6248 SOUTH TROY CIRCLE
UNIT A
CENTENNIAL,  CO  80111
Applicant Contact SARAH L SHIPPERT
Correspondent
SHIPPERT MEDICAL TECHNOLOGIES CORP.
6248 SOUTH TROY CIRCLE
UNIT A
CENTENNIAL,  CO  80111
Correspondent Contact SARAH L SHIPPERT
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received07/06/2009
Decision Date 08/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
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