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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Trousers, Anti-Shock
510(k) Number K953763
Device Name GLADIATOR ANTISHOCK PANTS
Applicant
Jobst Institute, Inc.
5825 Carnegie Blvd.
Charlotte,  NC  28209
Applicant Contact ANGELO R PEREIRA
Correspondent
Jobst Institute, Inc.
5825 Carnegie Blvd.
Charlotte,  NC  28209
Correspondent Contact ANGELO R PEREIRA
Regulation Number870.5800
Classification Product Code
LHX  
Date Received08/11/1995
Decision Date 11/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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