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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 K052725
Device Name PROTECTOR NEEDLE SHEATH PROP
Applicant
Certol International, LLC
4655 Kirkwood Ct.
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
Certol International, LLC
4655 Kirkwood Ct.
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/29/2005
Decision Date 12/28/2005
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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