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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 K890620
Device Name STICK-GARD SAFETY NEEDLE
Applicant
Ziehm International, Inc.
1886 Santa Anita Ave.,
South El Monte,  CA  91733
Applicant Contact ANN NADLER
Correspondent
Ziehm International, Inc.
1886 Santa Anita Ave.,
South El Monte,  CA  91733
Correspondent Contact ANN NADLER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/07/1989
Decision Date 02/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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