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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K971066
Device Name TAMARYN I.V. FLOW REGULATOR EXTENSION SET
Applicant
Tamaryn Medical Systems, Inc.
6539 S. 2475 E.
Salt Lake City,  UT  84121
Applicant Contact JIM KEANE
Correspondent
Tamaryn Medical Systems, Inc.
6539 S. 2475 E.
Salt Lake City,  UT  84121
Correspondent Contact JIM KEANE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/24/1997
Decision Date 06/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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