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510(k) K951854

Device
LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY
Applicant
LEONARD MEDICAL, INC.
510(k) number
K951854
Product code
FQO  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-21
Date received
1995-04-21
Regulation
878.4960
Classification name
Table, Operating-room, Ac-powered
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
LEONARD J BONNELL
Address
1464 Holcomb Rd. Huntingdon Valley PA US 19006 19006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FQO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240598Maestro System (REF100)Moon Surgical2024-06-03
K221410Maestro PlatformMoon Surgical2022-12-02
K090136STERIS CMAX XLT SURGICAL TABLESTERIS Corporation2009-03-20
K972810OPT80 THE TRANSPORTABLE (OPT80)O.P.T. USA, Inc.1997-08-26
K971988ALLEN, ULTRA AND SMART SOCKETSAllen Medical Systems, Inc.1997-07-11
K971307AMSCO SURGICAL TABLESTERIS Corporation1997-06-27
K963506TENET RADIOLUCENT HAND TABLETenet Medical Engineering1997-01-09
K961886DRAGER GEMINA WALL-MOUNTED WORKPLACEAlm Surgical Equipment, Inc.1996-07-30
K961742DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEMAlm Surgical Equipment, Inc.1996-07-26
K955750TELETOMBerchtold Holding GmbH1996-02-08
K953980KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORTKreuzer Corp.1995-11-16
K950192SKYTRON SKYBOOM SERIESSkytron, Div. the Kmw Group, Inc.1995-04-03
K926463RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCESMidmark Corp.1994-10-21
K942486IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLEMdt Corp., Inc.1994-08-10
K942043DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032EAlm Surgical Equipment, Inc.1994-07-13

Legacy Summary#

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FDA Review#

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