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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name clamp, tubing, blood, automatic
510(k) Number K921993
Device Name ELS AUTOMATIC TUBING CLAMP SYSTEM
Applicant
ROCKY MOUNTAIN RESEARCH, INC.
2715 EAST 3300 SOUTH
SALT LAKE CITY,  UT  84109
Applicant Contact THERESE DAVY
Correspondent
ROCKY MOUNTAIN RESEARCH, INC.
2715 EAST 3300 SOUTH
SALT LAKE CITY,  UT  84109
Correspondent Contact THERESE DAVY
Regulation Number876.5820
Classification Product Code
FIG  
Date Received04/28/1992
Decision Date 01/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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