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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K964663
Device Name FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX
Applicant
Rmds, Inc.
1208 SE 104th Ave.
Vancouver,  WA  98664 -4740
Applicant Contact DELBERT L RICE
Correspondent
Rmds, Inc.
1208 SE 104th Ave.
Vancouver,  WA  98664 -4740
Correspondent Contact DELBERT L RICE
Regulation Number870.4450
Classification Product Code
DXC  
Date Received11/21/1996
Decision Date 12/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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