510(k) K042659

Device: MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
Applicant: MEDISISS
510(k) number: K042659
Product code: NON
Decision: Substantially Equivalent (SESE)
Decision date: 2005-02-14
Date received: 2004-09-28
Regulation: 876.1075
Classification name: Forceps, Biopsy, Non-electric, Reprocessed
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: BRANDI JAMES
Address: 2747 SW 6th St. Redmond OR US 97756 97756

FDA Registration Numbers#

3011024991
3032391

Source Documents#

Other 510(k) Records For Product Code NON #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K042648	REPROCESSED COLD BIOPSY FORCEPS	Sterilmed, Inc.	2005-07-20
K042594	VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS	Vanguard Medical Concepts, Inc.	2005-01-25

Legacy Summary#

summary

FDA Review#

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