510(k) K012574

Device: REPROCESSED FEMORAL COMPRESSION DEVICE
Applicant: STERILMED, INC.
510(k) number: K012574
Product code: NMF
Decision: Substantially Equivalent (SESE)
Decision date: 2002-07-18
Date received: 2001-08-09
Regulation: 870.4450
Classification name: Clamp, Vascular, Reprocessed
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: PATRICK FLEISCHHACKER
Address: 11400 73rd Ave. N Suite 100 Maple Grove MN US 55369 55369

Source Documents#

Other 510(k) Records For Product Code NMF #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K120204	REPROCESSED FEMORAL COMPRESSION DEVICE	Sterilmed, Inc.	2012-04-03
K011832	VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE	Vanguard Medical Concepts, Inc.	2001-12-21

Legacy Summary#

summary

FDA Review#

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