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510(k) K911932

Device
J105 JAMES SURGICAL SYSTEM I/A PACK
Applicant
O.R. SPECIALTIES, INC.
510(k) number
K911932
Product code
GZX  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-26
Date received
1991-04-30
Regulation
882.4525
Classification name
Instrument, Microsurgical
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JACK W HOWARD
Address
4749 Appletree Ln. Tuscaloosa AL US 35405 35405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GZX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932169MICROSURGICAL INSTRUMENTSAmerican Russian Medical Services, Inc.1993-07-20
K926048CLARUS ENDOSCOPIC BALL PROBEClarus Medical Systems, Inc.1993-04-07
K890216MICROSURGICAL KERATOMEKinetic Medical Products1989-02-16
K873933RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUMDowns Surgical , Ltd.1987-12-17
K873934RANGE OF CROCODILE ACTION INSTRUMENTSDowns Surgical , Ltd.1987-12-17
K862971MICRA MICROSURGICAL INSTRUMENTSCordis Corp.1986-08-25
K853161THE VICKERS STANDARD MICROSURGERY SETKeeler Instruments, Inc.1985-11-07
K853179VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HANDKeeler Instruments, Inc.1985-11-07
K853180VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDEDKeeler Instruments, Inc.1985-10-28
K853181VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDEDKeeler Instruments, Inc.1985-10-28
K831071UNIVERSAL INSTRU. SET FOR NEUROVASCULARProthia USA, Inc.1983-06-08
K810485DUJOVNY MICROSURGICAL SCISSORSAmerican V. Mueller1981-02-27

Legacy Summary#

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FDA Review#

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