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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K090727
Device Name IMM DENTAL IRRIGATION TUBING SET
Applicant
Innovative Medical Manufacturing Co.
7128 Staffordshire St.
Houston,  TX  77030
Applicant Contact JOSEPH J CHANG
Correspondent
Innovative Medical Manufacturing Co.
7128 Staffordshire St.
Houston,  TX  77030
Correspondent Contact JOSEPH J CHANG
Regulation Number872.4200
Classification Product Code
EBW  
Date Received03/19/2009
Decision Date 08/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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