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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 K031131
Device Name KLINIDRAPE SURGICAL DRAPES
Applicant
Molnlycke Health Care
826 Newton Yardley Rd.
Newton,  PA  18940
Applicant Contact LINDA A HENDRICKS
Correspondent
Molnlycke Health Care
826 Newton Yardley Rd.
Newton,  PA  18940
Correspondent Contact LINDA A HENDRICKS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received04/09/2003
Decision Date 06/10/2003
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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