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510(k) K941128

Device
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS
Applicant
OSTEONICS CORP.
510(k) number
K941128
Product code
BXB  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1994-12-08
Date received
1994-03-09
Regulation
890.5380
Classification name
Exerciser, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT A KOCH, J.D
Address
59 Rte. 17 Allendale NJ US 07401 07401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BXB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K072887G-TRAINER MEDICALAlter-G, Inc.2008-01-25
K003272FLO-BOOTDiscovery Group, LLC2001-04-04
K952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.1996-09-25
K953456E-Z FLEXFluid Motion Biotechnologies, Inc.1996-01-26
K955106BTE CPM-20Baltimore Therapeutic Equipment Co.1995-12-29
K955105BTE CPM-10Baltimore Therapeutic Equipment Co.1995-12-29
K951028HAMEX TWONorthern Orthopaedic Products, Inc.1995-12-11
K950755FLEXMATE K500Breg, Inc.1995-10-05
K951029HAMEX ONENorthern Orthopaedic Products, Inc.1995-09-15
K945733AQUAHAB, MODEL 120-72-101Aquarius Electronics, Inc.1995-09-15
K950682W2 WRIST CPM UNITToronto Medical Corp.1995-09-13
K952369KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLEPhysicians Consulting, Inc.1995-08-07
K945690BACKCYCLER CPM(TM)Ergomedics, Inc.1995-06-22
K946169ACTIC 2002North Atlantic Rehabilitation, Inc.1995-06-15
K945824GALAXY MD SERIES THERAPYPOOLSGalaxy Aquatics, Inc.1995-04-05

Legacy Summary#

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FDA Review#

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