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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 K020921
Device Name NO-POKES NEEDLE SAFETY DEVICE
Applicant
BEMIS MFG. CO.
300 MILL ST.
SHEBOYGAN FALLS,  WI  53085
Applicant Contact JOHN B HOWELL
Correspondent
BEMIS MFG. CO.
300 MILL ST.
SHEBOYGAN FALLS,  WI  53085
Correspondent Contact JOHN B HOWELL
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/21/2002
Decision Date 07/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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