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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 K971159
Device Name SURGICAL DRAPES
Applicant
International Medsurg Connection
1000 E. Woodfield Rd.
Suit3 117
Schaumberg,  IL  60173
Applicant Contact LARA N SIMMONS
Correspondent
International Medsurg Connection
1000 E. Woodfield Rd.
Suit3 117
Schaumberg,  IL  60173
Correspondent Contact LARA N SIMMONS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/31/1997
Decision Date 06/24/1997
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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