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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K915056
Device Name FINGGUARD
Applicant
Allied Signal, Inc.
Keller And Heckman Law Offices
1150 17th St., NW, Suite 1000
Washington,  DC  20038
Applicant Contact MELVIN DROZEN
Correspondent
Allied Signal, Inc.
Keller And Heckman Law Offices
1150 17th St., NW, Suite 1000
Washington,  DC  20038
Correspondent Contact MELVIN DROZEN
Regulation Number878.4040
Classification Product Code
LYU  
Date Received11/08/1991
Decision Date 02/03/1992
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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