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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
510(k) Number K913047
Device Name STERILESERT(TM) CABLE AND POLE DRAPE
Applicant
Arch Development Group
9648 Olive Blvd., Suite 411
St. Louis,  MO  63132
Applicant Contact ROBERT A ROTH
Correspondent
Arch Development Group
9648 Olive Blvd., Suite 411
St. Louis,  MO  63132
Correspondent Contact ROBERT A ROTH
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/09/1991
Decision Date 10/02/1991
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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