510(k) K120204

Device: REPROCESSED FEMORAL COMPRESSION DEVICE
Applicant: STERILMED, INC.
510(k) number: K120204
Product code: NMF
Decision: Substantially Equivalent (SESE)
Decision date: 2012-04-03
Date received: 2012-01-23
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: JASON SKRAMSTED
Address: 11140 73rd Ave. N. Maple Grove MN US 55369 55369

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10888551039482	NA	STERILMED, INC.	2016-09-22
10888551034814	NA	STERILMED, INC.	2016-09-22

Other 510(k) Records For Product Code NMF #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K012574	REPROCESSED FEMORAL COMPRESSION DEVICE	Sterilmed, Inc.	2002-07-18
K011832	VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE	Vanguard Medical Concepts, Inc.	2001-12-21

Legacy Summary#

summary

FDA Review#

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