510(k) K011832

Device: VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
Applicant: VANGUARD MEDICAL CONCEPTS, INC.
510(k) number: K011832
Product code: NMF
Decision: Substantially Equivalent (SESE)
Decision date: 2001-12-21
Date received: 2001-06-12
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: MIKE SAMMON
Address: 5307 Great Oak Dr. Lakeland FL US 33815 33815

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
K012574	REPROCESSED FEMORAL COMPRESSION DEVICE	Sterilmed, Inc.	2002-07-18

Legacy Summary#

summary

FDA Review#

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