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510(k) K963505

Device
TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
Applicant
TENET MEDICAL ENGINEERING
510(k) number
K963505
Product code
HHP  
Decision
Substantially Equivalent (SESE)
Decision date
1997-02-14
Date received
1996-09-03
Regulation
884.4900
Classification name
Table, Obstetrical, Manual (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KEN MOORE
Address
3553 31st St., NW Calgary CA T2L 2K7 T2L 2K7

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HHP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822812YSI MODEL 23L LACTATE ANALYZERYellow Springs Instrument Co., Inc.1982-12-13

Legacy Summary#

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FDA Review#

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