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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Elastomeric
510(k) Number K061409
Device Name SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
Applicant
Precise Medical Products, Ltd.
Dora St. (Industrial Zone)
Shlomi,  IL 22832
Applicant Contact OFER SHAY
Correspondent
Precise Medical Products, Ltd.
Dora St. (Industrial Zone)
Shlomi,  IL 22832
Correspondent Contact OFER SHAY
Regulation Number880.5725
Classification Product Code
MEB  
Date Received05/22/2006
Decision Date 06/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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