510(k) K980016

Device: MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
Applicant: GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
510(k) number: K980016
Product code: MOP
Decision: Substantially Equivalent (SESE)
Decision date: 1998-08-07
Date received: 1998-01-02
Regulation: 870.3935
Classification name: Rotator, Prosthetic Heart Valve
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: ROSINA ROBINSON
Address: 49 Plain St. North Attleboro MA US 02760 02760

Source Documents#

Other 510(k) Records For Product Code MOP #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K974648	SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR	Sulzer Carbomedics, Inc.	1998-08-04
K960923	CARBOMEDICS MITRAL ROTATOR	Carbomedics, Inc.	1996-04-29
K951368	CARBOMEDICS EXENDED MITRAL ROTATOR	Carbomedics, Inc.	1995-06-20

Legacy Summary#

summary

FDA Review#

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