510(k) K050933

Device: FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
Applicant: MEDISURG LTD.
510(k) number: K050933
Product code: NCR
Decision: Substantially Equivalent (SESE)
Decision date: 2005-12-09
Date received: 2005-04-14
Regulation: 886.4100
Classification name: Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-powered
Medical specialty: Ophthalmic
Review panel: Ophthalmic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: RICHARD J FUGO
Address: 100 W. Fornance St. The Fugo Bldg. Norristown PA US 19401 19401

FDA Registration Numbers#

3009905888

Source Documents#

Other 510(k) Records For Product Code NCR #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K041019	THE FUGO BLADE FOR GLAUCOMA	Medisurg , Ltd.	2004-10-08
K001498	THE FUGO BLADE	Medisurg , Ltd.	2000-08-10

Legacy Summary#

summary

FDA Review#

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