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510(k) K934583

Device
BURRS
Applicant
AMERICAN MEDICAL SPECIALTIES, INC.
510(k) number
K934583
Product code
GFF  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-26
Date received
1993-09-23
Regulation
878.4820
Classification name
Bur, Surgical, General & Plastic Surgery
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
ROGER EAGLEN
Address
1080 Holcomb Bridge Rd.. Bldg. 100 Suite 300 Roswell GA US 30076 30076

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GFF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974025ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.1998-07-06
K950449SURGICAL BURTransidyne General Corp.1995-03-01
K943758SURGICAL BURKomet Medical1994-08-22
K894438MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTSMicro-Aire Surgical Instruments, Inc.1989-08-21
K890090DANEK IRRIGATING BURR (DIB) SETDanek Medical, Inc.1989-01-24
K883255KOMET SURGICAL BURKomet Medical, Div. of Brasseler USA I, L.P.1988-09-15
K880859SURGICAL BURSNew England Surgical Instrument Corp.1988-03-21
K880706SURGICAL BURSNuell Air Equipment & Hospital Supplies, Inc.1988-02-26
K872475SURGICAL BURTava Surgical Instruments1987-07-02
K862852MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTRMicro-Aire Surgical Instruments, Inc.1986-08-11
K853658BURS FOR MICRO SURGICAL DRILL SYSTEMAcumed Instruments Corp.1985-09-24
K850497MICRO-AIRE GENERIC BURS & DRILLSMicro-Aire Surgical Instruments, Inc.1985-03-01
K841298HOLE CHAMFERING DEVICETechmedica, Inc.1984-04-25
K821485DERMABRADERSSpire Medical, Inc.1982-06-10
K820281MICRO-AIRE REPLACEMENT DRILL BURSMicro-Aire Surgical Instruments, Inc.1982-02-23

Legacy Summary#

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FDA Review#

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