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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Surgical
510(k) Number K913700
Device Name DISPOSABLE BOUFFANT CAP
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
FYF  
Date Received08/19/1991
Decision Date 10/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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