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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K873997
Device Name ANTI-SHOCK TROUSERS
Applicant
Simulaids, Inc.
P.O. Box 807, 12 Dixon Ave.
Woodstock,  NY  12498
Applicant Contact KEVIN M SWEENEY
Correspondent
Simulaids, Inc.
P.O. Box 807, 12 Dixon Ave.
Woodstock,  NY  12498
Correspondent Contact KEVIN M SWEENEY
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/01/1987
Decision Date 12/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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