510(k) K063844

Device: REPROCESSED HEART STABILIZERS AND POSITIONERS
Applicant: STERILMED, INC.
510(k) number: K063844
Product code: NQG
Decision: Substantially Equivalent (SESE)
Decision date: 2007-03-15
Date received: 2006-12-26
Regulation: 870.4500
Classification name: Stabilizer, Heart, Non-compression, Reprocessed
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DENNIS TOUSSAINT
Address: 11140 73rd Ave. N. Maple Grove MN US 55369 55369

FDA Registration Numbers#

2011171

Source Documents#

Other 510(k) Records For Product Code NQG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K070034	REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES	Ascent Healthcare Solutions	2007-08-17
K070036	REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES	Ascent Healthcare Solutions	2007-08-17

Legacy Summary#

summary

FDA Review#

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