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510(k) K831071

Device
UNIVERSAL INSTRU. SET FOR NEUROVASCULAR
Applicant
PROTHIA USA, INC.
510(k) number
K831071
Product code
GZX  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-08
Date received
1983-04-04
Regulation
882.4525
Classification name
Instrument, Microsurgical
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K911932J105 JAMES SURGICAL SYSTEM I/A PACKO.R. Specialties, Inc.1991-08-26
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
K810485DUJOVNY MICROSURGICAL SCISSORSAmerican V. Mueller1981-02-27

Legacy Summary#

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FDA Review#

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