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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K143095
Device Name MiniStim MS-IVB Peripheral Nerve Stimulator
Applicant
Halyard Health, Inc.
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Applicant Contact Lindsey Hedlund
Correspondent
Halyard Health, Inc.
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Correspondent Contact Lindsey Hedlund
Regulation Number868.2775
Classification Product Code
BXN  
Date Received10/28/2014
Decision Date 03/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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