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510(k) K894301

Device
MICRO-AIRE STERNUM SAW 4800
Applicant
MICRO SURGICAL INSTRUMENTS CORP.
510(k) number
K894301
Product code
KFK  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-03
Date received
1989-06-23
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#

Contact
SIDDHARTH DESAI
Address
24971 Ave. Stanford W. Valencia CA US 91355 91355

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
K870157OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMERMicro-Aire Surgical Instruments, Inc.1987-02-24
K801737STERNUM SAWAmsco Co.1980-08-20

Legacy Summary#

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FDA Review#

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