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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K041941
Device Name SAFE T RETRACTABLE BLOOD COLLECTION DEVICE
Applicant
Safe T Medical Devices, Ltd.
P.O. Box 1070
Conway,  NH  03818
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Safe T Medical Devices, Ltd.
P.O. Box 1070
Conway,  NH  03818
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/19/2004
Decision Date 09/13/2004
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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