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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 K061492
Device Name MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
Applicant
Tyco Healthcare
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact MICHELLE KELLEY
Correspondent
Tyco Healthcare
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact MICHELLE KELLEY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/31/2006
Decision Date 08/03/2006
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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