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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 K083851
Device Name INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
Applicant
Inviro Medical Devices, Inc.
1755 N. Brown Rd.
Suite 150
Lawrenceville,  GA  30043
Applicant Contact JIM BARLEY
Correspondent
Inviro Medical Devices, Inc.
1755 N. Brown Rd.
Suite 150
Lawrenceville,  GA  30043
Correspondent Contact JIM BARLEY
Regulation Number880.5440
Classification Product Code
LHI  
Date Received12/24/2008
Decision Date 05/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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