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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 K964662
Device Name FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
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 02/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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