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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 K821696
Device Name THE SOFT PEDAL
Applicant
HABCO PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HABCO PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/08/1982
Decision Date 07/14/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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