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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K933148
Device Name SURGICAL DRAPE KIT
Applicant
Nobelpharma USA, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact ALAN I BECKER
Correspondent
Nobelpharma USA, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact ALAN I BECKER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received06/29/1993
Decision Date 06/26/1995
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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