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510(k) K884473

Device
RUBIN BONE PLANER W/REPLACEABLE BLADE
Applicant
NEO CONTEMPORARY CO.
510(k) number
K884473
Product code
GAC  
Decision
Substantially Equivalent (SESE)
Decision date
1988-12-09
Date received
1988-10-25
Regulation
878.4800
Classification name
Rasp, Surgical, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ERROL B RUBIN
Address
795a Southern Artery Quincy MA US 02169 02169

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K853601MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASPBowen & Company, Inc.1985-09-16

Legacy Summary#

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FDA Review#

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