ClearanceBrief
510(k) K061409 ยท MEB Pump, Infusion, Elastomeric

SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET

ApplicantPrecise Medical Products, Ltd., Shlomi, IL
DecisionSubstantially Equivalent, Jun 16, 2006
ReceivedMay 22, 2006
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K061409

DateFirm and productCodeLinked 510(k)
Apr 14, 2011Hsmg, Inc. D/b/a Smartinfuser Usa
SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD.
Terminated		 MEBNone listed
Mar 8, 2010Hsmg, Inc. D/b/a Smartinfuser Usa
SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.
Terminated		 MEBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.