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510(k) K964102

Device
TENET TIBIAL FRACTURE SUPPORT
Applicant
TENET MEDICAL ENGINEERING
510(k) number
K964102
Product code
GBB  
Decision
Substantially Equivalent (SESE)
Decision date
1996-12-05
Date received
1996-10-11
Regulation
878.4960
Classification name
Chair, Surgical, Ac-powered
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KEN MOORE
Address
2nd. Floor 2004 - 10 Ave. SW Calgary Alberta CA T3C OJ8 T3C OJ8

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893598HYDRAULIC FOOT OPERATED STOOLArthro-Medic, Inc.1989-10-10
K831325NUTROMATMedlog GmbH Marketing Services1983-06-02
K831385LITHOTOMY CHAIR #415Midmark Corp.1983-06-02
K822264NAGASHIMA SN OPERATOR'S CHAIRKelleher Corp.1982-10-13
K822251EXAMINATION & TREATMENT CHAIRSKelleher Corp.1982-08-27
K822013NAGASHIMA SN AUTOMATIC TREATMENT CHAIRKelleher Corp.1982-07-28
K820636STORZ #6500 POWER EXAMINATION CHAIRStorz Instrument Co.1982-03-26

Legacy Summary#

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FDA Review#

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