510(k) K033578

Device: REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS
Applicant: CLEAR MEDICAL, INC.
510(k) number: K033578
Product code: NLL
Decision: Substantially Equivalent (SESE)
Decision date: 2005-07-11
Date received: 2003-11-13
Regulation: 878.4750
Classification name: Staple, Implantable, Reprocessed
Medical specialty: General & Plastic Surgery
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MIKE KOVACS
Address: 1776 136th Pl. NE Bellevue WA US 98005 98005

Source Documents#

Other 510(k) Records For Product Code NLL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K070930	REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS	Sterilmed, Inc.	2007-10-18
K070859	REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS	Sterilmed, Inc.	2007-09-12

Legacy Summary#

summary

FDA Review#

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