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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K844705
Device Name SHOE COVERS
Applicant
Medicon, Inc.
143 New Canaan Ave.
Norwalk,  CT  06850
Applicant Contact JAMES C NICHOLAS
Correspondent
Medicon, Inc.
143 New Canaan Ave.
Norwalk,  CT  06850
Correspondent Contact JAMES C NICHOLAS
Regulation Number878.4040
Classification Product Code
FXP  
Date Received12/03/1984
Decision Date 01/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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