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510(k) K904352

Device
CODMAN COLLINS RADIOPARENT STERNAL BLADES
Applicant
Codman & Shurtleff, Inc.
510(k) number
K904352
Product code
DWH  
Decision
Substantially Equivalent (SESE)
Decision date
1990-11-21
Date received
1990-09-24
Regulation
878.4820
Classification name
Blade, Saw, Surgical, Cardiovascular
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JEANETTE CLOUTIER
Address
41 Pacella Park Dr. Randolph Industrial Park Randolph MA US 02368 02368

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DWH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862474HALL STERNUM SAWHall Surgical, Division of Zimmer, Inc.1986-07-17
K850483MICRO-AIRE STERNUM SAW REPLACEMENT BLADESMicro-Aire Surgical Instruments, Inc.1985-03-01
K830189CARDIOVASCULAR SAW BLADESTemp Medical Products, Inc.1983-03-24

Legacy Summary#

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FDA Review#

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