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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 K913628
Device Name DISPOSABLE SHOE COVER
Applicant
Gem Nonwovews, Inc.
2800-E Bob Wallace Ave.
Huntsville,  AL  35805
Applicant Contact JAMES MCLAUGHLIN
Correspondent
Gem Nonwovews, Inc.
2800-E Bob Wallace Ave.
Huntsville,  AL  35805
Correspondent Contact JAMES MCLAUGHLIN
Regulation Number878.4040
Classification Product Code
FXP  
Date Received08/15/1991
Decision Date 10/04/1991
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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