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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K092430
Device Name 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
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 Number880.5860
Classification Product Code
MEG  
Date Received08/07/2009
Decision Date 09/04/2009
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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