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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 K040036
Device Name INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
Applicant
Inviro Medical
28481 La Falda
Laguna Niguel,  CA  92677
Applicant Contact JIM BARLEY
Correspondent
Inviro Medical
28481 La Falda
Laguna Niguel,  CA  92677
Correspondent Contact JIM BARLEY
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/09/2004
Decision Date 03/18/2004
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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