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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 K904903
Device Name PARADERM(TM) SURGEON'S GLOVE ACCESSORY
Applicant
Lovell-Schenck, Inc.
C/O Keller & Heckman
1150 17th St., NW, Suite 1000
Washington,  DC  20036
Applicant Contact MELVIN S DROZEN
Correspondent
Lovell-Schenck, Inc.
C/O Keller & Heckman
1150 17th St., NW, Suite 1000
Washington,  DC  20036
Correspondent Contact MELVIN S DROZEN
Regulation Number878.4040
Classification Product Code
LYU  
Date Received10/29/1990
Decision Date 01/08/1991
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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