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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 K944763
Device Name CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER
Applicant
Wells Lamont Corp.
6640 W. Touhy Ave.
Niles,  IL  60714
Applicant Contact WELLS LAMONT
Correspondent
Wells Lamont Corp.
6640 W. Touhy Ave.
Niles,  IL  60714
Correspondent Contact WELLS LAMONT
Regulation Number878.4040
Classification Product Code
LYU  
Date Received09/27/1994
Decision Date 04/10/1995
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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