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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 K890101
Device Name FEMORAL ANGIOGRAPHY DRAPE
Applicant
Medical Plastics, Inc.
1050 Northfield Ct.
Suite 300
Roswell,  GA  30076
Applicant Contact JOSEPH PRINCE
Correspondent
Medical Plastics, Inc.
1050 Northfield Ct.
Suite 300
Roswell,  GA  30076
Correspondent Contact JOSEPH PRINCE
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/10/1989
Decision Date 03/16/1989
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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