510(k) K070930

Device: REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
Applicant: STERILMED, INC.
510(k) number: K070930
Product code: NLL
Decision: Substantially Equivalent (SESE)
Decision date: 2007-10-18
Date received: 2007-04-03
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: DENNIS TOUSSAINT
Address: 11400 73rd Ave. N Maple Grove MN US 55369 55369

Source Documents#

Other 510(k) Records For Product Code NLL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K070859	REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS	Sterilmed, Inc.	2007-09-12
K033578	REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS	Clearmedical, Inc.	2005-07-11

Legacy Summary#

summary

FDA Review#

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