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510(k) K925005

Device
ISI SELF-SUPPORTING ARM
Applicant
INSTRUMENTATION SPECIALTIES, INC.
510(k) number
K925005
Product code
BWN  
Decision
Substantially Equivalent (SESE)
Decision date
1993-04-29
Date received
1992-10-02
Regulation
878.4950
Classification name
Table And Attachments, Operating-room
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH R KABANEK
Address
32390 Ih-10 W. Boerne TX US 78006 78006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BWN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K942699AIRFRAME SURGICAL DRAPE SUPPORTAlpha Surgical, Inc.1994-07-13
K935441INFINITECH BREATH EZInfinitech, Inc.1994-02-07
K922288HOLDER, PEDIATRIC POSITIONYamashita and Hemsley Business Trust1993-02-10
K910783SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604MSmith & Nephew Equipment Group1991-04-02
K902865BAUMER SURGICAL TABLESds Dental, Inc.1990-09-10
K884558IOP ADJUSTABLE STIRRUPMend Technologies, Inc.1988-11-17
K875291SPINAL SURGERY FRAMET. Korossurgical Instruments Corp.1988-01-22
K873272ENDOSCOPY TABLE 1532 ENDOSTARStierlen-Maquet AG1987-09-08
K860177ALLEN UNIVERSAL STIRRUPEdgewater Medical Equipment Systems1986-02-11
K852332TABLE ACCESSORIES, OPERATING ROOMScholten Surgical Instruments, Inc.1985-07-02
K843121GUIDE TO THE KNEEDyonics, Inc.1984-09-07
K832340OPERATING ROOM TABLES HYDRAULICKamiya Tsusan Kaisha, Ltd.1983-08-12
K823772AMSCO ORTHOGRAPHIC 2 TABLEAmerican Sterilizer Co.1983-01-14
K820574ARMBOARD FOR INTRAVENOUS ANES. IN DENTALDavid Simmonds Co., Inc.1982-03-23
K812396ARTHRO-PREP RESTNorthwest Surgical Concepts, Inc.1981-11-20

Legacy Summary#

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FDA Review#

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