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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Bubble, Cardiopulmonary Bypass
510(k) Number K961598
Device Name ELS AUTOMATIC TUBING CLAMP SYSTEM
Applicant
Rocky Mountain Research, Inc.
2715 E. 3300 S.
Salt Lake City,  UT  84109
Applicant Contact ROBERT W GRIFFITHS
Correspondent
Rocky Mountain Research, Inc.
2715 E. 3300 S.
Salt Lake City,  UT  84109
Correspondent Contact ROBERT W GRIFFITHS
Regulation Number870.4205
Classification Product Code
KRL  
Date Received04/09/1996
Decision Date 10/29/1996
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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