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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 K050538
Device Name IMC DRAPES
Applicant
Intl. Medsurg Connection, Inc.
935 N Plum Grove Rd., Suite F
Schaumburg,  IL  60173
Applicant Contact MANNY GUPTA
Correspondent
Intl. Medsurg Connection, Inc.
935 N Plum Grove Rd., Suite F
Schaumburg,  IL  60173
Correspondent Contact MANNY GUPTA
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/02/2005
Decision Date 06/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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