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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 K910221
Device Name RMI VASCULAR TOURNIQUET KIT
Applicant
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Applicant Contact MICHAEL N KELLY
Correspondent
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Correspondent Contact MICHAEL N KELLY
Regulation Number870.4450
Classification Product Code
DXC  
Date Received01/17/1991
Decision Date 05/16/1991
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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