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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cylinder, Compressed Gas, And Valve
510(k) Number K142149
Device Name OXYTOTE INFINITY SERIES VIPR SYSTEMS
Applicant
WESTERN/SCOTT FETZER CO.
875 BASSETT RD.
WESTLAKE,  OH  44145 -1142
Applicant Contact DAVID C SIMO
Correspondent
WESTERN/SCOTT FETZER CO.
875 BASSETT RD.
WESTLAKE,  OH  44145 -1142
Correspondent Contact DAVID C SIMO
Regulation Number868.2700
Classification Product Code
ECX  
Date Received08/05/2014
Decision Date 04/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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