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510(k) K896589

Device
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
Applicant
OPTIK
510(k) number
K896589
Product code
LRZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-12-27
Date received
1989-11-21
Regulation
878.4800
Classification name
Screwdriver, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM M MACFIE
Address
2131espey Ct. Suite 7 Criftib MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LRZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K8724901.1 SCREWDRIVERSMicro-Aire Surgical Instruments, Inc.1987-07-23
K872387STANDARD SCREW DRIVERMed-Tool, Inc.1987-07-16

Legacy Summary#

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FDA Review#

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