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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K101359
Device Name INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
Applicant
INVIRO MEDICAL DEVICES, INC.
1755 NORTH BROWN ROAD
SUITE 150
LAWRENCEVILLE,  GA  30043
Applicant Contact JIM BARLEY
Correspondent
INVIRO MEDICAL DEVICES, INC.
1755 NORTH BROWN ROAD
SUITE 150
LAWRENCEVILLE,  GA  30043
Correspondent Contact JIM BARLEY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/14/2010
Decision Date 08/20/2010
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
Recalls CDRH Recalls
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