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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 K050797
Device Name TISSU-TRANS
Applicant
Shippert Medical Technologies Corp.
6248 S. Troy Cir.
Unit A
Centennial,  CO  80111
Applicant Contact SARAH LAKE
Correspondent
Shippert Medical Technologies Corp.
6248 S. Troy Cir.
Unit A
Centennial,  CO  80111
Correspondent Contact SARAH LAKE
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received03/29/2005
Decision Date 07/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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