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510(k) K935225

Device
MITEK MODULAR DRILL BIT
Applicant
MITEK SURGICAL PRODUCTS, INC.
510(k) number
K935225
Product code
GFG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-07
Date received
1993-11-01
Regulation
878.4820
Classification name
Bit, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Robert Zoletti
Address
57 Providence Hwy. Norwood MA US 02062 02062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GFG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K821486MICRO DRILLSSpire Medical, Inc.1982-06-09
K821127KEY DRILLKey Medical, Inc.1982-06-03

Legacy Summary#

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FDA Review#

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