510(k) K013360

Device: DFINER UROLOGICAL CATHETER
Applicant: NEOSEED TECHNOLOGY,LLC
510(k) number: K013360
Product code: FGI
Decision: Substantially Equivalent (SESE)
Decision date: 2002-02-20
Date received: 2001-10-10
Regulation: 876.5130
Classification name: Catheter, Urethrographic, Male
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MARK KIERAS
Address: 22 Hill St. Newburyport MA US

FDA Registration Numbers#

1923569

Source Documents#

Other 510(k) Records For Product Code FGI #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K023019	VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000	Vomed Volzer Medizintechnik GmbH & Co.	2002-12-10
K810370	POLLACK CHAIN CYSOURETHROGRAM SET	Vance Products, Inc.	1981-03-20

Legacy Summary#

summary

FDA Review#

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