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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 K161323
Device Name Solution Set for Epidural Use
Applicant
BAXTER HEALTHCARE CORPORATION
32650 N. WILSON ROAD
ROUND LAKE,  IL  60073
Applicant Contact Tiffany Lin
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/11/2016
Decision Date 11/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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