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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 K861531
Device Name DISPOSABLE SURGICAL DRAPES AND ACCESSORIES
Applicant
Medical Concepts Development, Inc.
330 Chester St.
St. Paul,  MN  55107
Applicant Contact LEE W ANNETT
Correspondent
Medical Concepts Development, Inc.
330 Chester St.
St. Paul,  MN  55107
Correspondent Contact LEE W ANNETT
Regulation Number878.4370
Classification Product Code
KKX  
Date Received04/24/1986
Decision Date 05/23/1986
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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