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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K161800
Device Name OnSite-IV
Applicant
Pharmc, LLC
6655 N. Vista Lane
Jackson,  WY  83001
Applicant Contact CHRIS TICE
Correspondent
Medtech Consultants
20370 Skyhawk Lane
Topanga,  CA  90290
Correspondent Contact SIGI CARON
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/30/2016
Decision Date 12/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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