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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K071307
Device Name INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003
Applicant
Inviro Medical Devices, Inc.
3235 Satellite Blvd.
Bldg. 400, Suite 300
Duluth,  GA  30096
Applicant Contact JIM BARLEY
Correspondent
Inviro Medical Devices, Inc.
3235 Satellite Blvd.
Bldg. 400, Suite 300
Duluth,  GA  30096
Correspondent Contact JIM BARLEY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/09/2007
Decision Date 02/12/2008
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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