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510(k) K801737

Device
STERNUM SAW
Applicant
AMSCO CO.
510(k) number
K801737
Product code
KFK  
Decision
Substantially Equivalent (SESE)
Decision date
1980-08-20
Date received
1980-07-25
Regulation
878.4820
Classification name
Saw, Pneumatically Powered
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KFK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893949#157 EXAM LIGHTMedmark, Inc.1989-08-07
K894301MICRO-AIRE STERNUM SAW 4800Micro Surgical Instruments Corp.1989-08-03
K870157OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMERMicro-Aire Surgical Instruments, Inc.1987-02-24

Legacy Summary#

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FDA Review#

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