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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Vascular
510(k) Number K920676
Device Name RMI SOFCLAMP
Applicant
Research Medical, Inc.
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact RD HIBBERT
Correspondent
Research Medical, Inc.
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact RD HIBBERT
Regulation Number870.3250
Classification Product Code
DSS  
Date Received02/14/1992
Decision Date 04/15/1992
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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