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510(k) K874961

Device
BONE CUTTING INSTRUMENTS & ACCESSORIES
Applicant
SOLWAY, INC.
510(k) number
K874961
Product code
GDR  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-30
Date received
1987-12-02
Regulation
878.4800
Classification name
Saw, Manual And Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARTIN MUNZER
Address
Post Office Box 7647 Hollywood FL US 33081 33081

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K85178727-100 TO 29-130 VARIOUS BONE SAWS-CHARRIERE, SATTArtiberia1985-06-20

Legacy Summary#

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FDA Review#

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