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510(k) K870780

Device
ACROMED WALLIE-HEINIG OSTEOTOMES
Applicant
BUCKMAN CO., INC.
510(k) number
K870780
Product code
HWM  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-09
Date received
1987-02-26
Regulation
878.4800
Classification name
Osteotome
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID W SCHLERF
Address
921 Calle Verde Martinez CA US 94553 94553

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874503MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTERMicro-Aire Surgical Instruments, Inc.1987-12-02
K771744OSTEOTOMES FOR CUTTING BONHDepuy, Inc.1977-09-28

Legacy Summary#

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FDA Review#

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