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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 K874774
Device Name TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
Applicant
Vinyl Technology, Inc.
2110 Edwards Ave.
So. El Monte,  CA  91733
Applicant Contact CARLOS A MOLLURA
Correspondent
Vinyl Technology, Inc.
2110 Edwards Ave.
So. El Monte,  CA  91733
Correspondent Contact CARLOS A MOLLURA
Regulation Number870.5800
Classification Product Code
LHX  
Date Received11/19/1987
Decision Date 02/08/1988
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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