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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 K070203
Device Name INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
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 Number880.5860
Classification Product Code
MEG  
Date Received01/22/2007
Decision Date 04/23/2007
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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