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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K896088
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 Number892.1600
Classification Product Code
IZI  
Date Received10/19/1989
Decision Date 11/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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