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510(k) K953763

Device
GLADIATOR ANTISHOCK PANTS
Applicant
JOBST INSTITUTE, INC.
510(k) number
K953763
Product code
LHX  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-28
Date received
1995-08-11
Regulation
870.5800
Classification name
Trousers, Anti-shock
Medical specialty
Cardiovascular
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANGELO R PEREIRA
Address
5825 Carnegie Blvd. Charlotte NC US 28209 28209

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LHX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874774TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERSVinyl Technology, Inc.1988-02-08
K841605BP TRAUMA AIR PANTSBp Medical Systems, Inc.1984-07-06
K812564ZEE LIFE SUPPORT AIR PANTSZee Medical Products Co., Inc.1981-10-23

Legacy Summary#

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FDA Review#

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