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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
510(k) Number K823737
Device Name MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT
Applicant
Gotfried Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gotfried Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5780
Classification Product Code
DWL  
Date Received12/13/1982
Decision Date 01/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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