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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 K041590
Device Name AUTODETECT SYRINGE
Applicant
Indigo Orb, Inc.
2355 Calle De Luna
Santa Clara,  CA  95054
Applicant Contact ROBERT CHIN
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/14/2004
Decision Date 06/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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