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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty
510(k) Number K092482
Device Name TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
Applicant
Shippert Medical Technologies Corp.
6248 S. Troy Circle
Unit A
Centennial,  CO  80111
Applicant Contact SARAH L SHIPPERT
Correspondent
Shippert Medical Technologies Corp.
6248 S. Troy Circle
Unit A
Centennial,  CO  80111
Correspondent Contact SARAH L SHIPPERT
Regulation Number878.5040
Classification Product Code
MUU  
Date Received08/13/2009
Decision Date 12/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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