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510(k) K974648

Device
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
Applicant
SULZER CARBOMEDICS, INC.
510(k) number
K974648
Product code
MOP  
Decision
Substantially Equivalent (SESE)
Decision date
1998-08-04
Date received
1997-12-12
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
EDWARD E NEWTON
Address
1300 E. Anderson Ln. Austin TX US 78752 78752

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K980016MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLEGenzyme Surgical Product (Genzyme Biosurgery)1998-08-07
K960923CARBOMEDICS MITRAL ROTATORCarbomedics, Inc.1996-04-29
K951368CARBOMEDICS EXENDED MITRAL ROTATORCarbomedics, Inc.1995-06-20

Legacy Summary#

summary

FDA Review#

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