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510(k) K853601

Device
MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP
Applicant
BOWEN & COMPANY, INC.
510(k) number
K853601
Product code
GAC  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-16
Date received
1985-08-27
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
CAROL APPLE
Address
1800 Chapman Ave. Rockville MD US 20852 20852

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
K884473RUBIN BONE PLANER W/REPLACEABLE BLADENeo Contemporary Co.1988-12-09

Legacy Summary#

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FDA Review#

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