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510(k) K936050

Device
JAW SPREADER
Applicant
GAM INDUSTRIES, INC.
510(k) number
K936050
Product code
KBW  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-24
Date received
1993-12-20
Regulation
874.4420
Classification name
Screw, Oral
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GARY J BEDEN
Address
P.O. Box 2226 Petersburg VA US 23804 23804

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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