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510(k) K841388

Device
ACUFEX SHOULDER HOLDER
Applicant
ACUFEX MICROSURGICAL, INC.
510(k) number
K841388
Product code
HST  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-16
Date received
1984-04-03
Regulation
888.5850
Classification name
Apparatus, Traction, Non-powered
Medical specialty
Orthopedic
Review panel
Neurology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HST  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression TableStl International, Inc.2016-12-30
K110858LO-BAK TRAXRoland F Berthiaume, DC2011-08-02
K984190BACK-ON-TRAC, MODEL 101BOTBack-On-Track, Inc.1999-03-15
K872121K AND D HOME TRACTJoseph A. Kott, M.D.1987-08-12
K870212ARTHROSCOPIC SHOULDER HOLDERDyonics, Inc.1987-02-20
K870125EXTREMITY ELEVATOROrthopedic Systems, Inc.1987-02-04
K870102TUPPER TROLLEYOrthopedic Systems, Inc.1987-02-03
K864765MODEL 668, TRACTION SPLINT, ADULTFerno-Washington, Inc.1986-12-17
K862874THE TOWERED 90/90 UNITLossing Orthopedic, Inc.1986-08-07
K855179TRANSFER-TRAX (TM) SPLINT TRACTIONComfortex, Inc.1986-01-21
K860037SUSPENDER ORTHOPEDIC SUSPENSION DEVICEComfortex, Inc.1986-01-21
K844239NEC-KRADLE BY VENCORVencor1984-11-19
K841368HYPERBARIC OXYGEN GURNEY-Orthopedic Systems, Inc.1984-05-16
K831888COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYGPortable Travtion Device Co.1983-07-12
K830244TRACTION ACCESSORIESWarm & Form, Orthopedic Materials1983-03-09

Legacy Summary#

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FDA Review#

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