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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Reusable
510(k) Number K881784
Device Name KLEIN NEEDLE
Applicant
E.L. MEDICO INTL., INC.
POST OFFICE BOX 1268
SAN CLEMENTE,  CA  92672
Applicant Contact JEFF KLEIN
Correspondent
E.L. MEDICO INTL., INC.
POST OFFICE BOX 1268
SAN CLEMENTE,  CA  92672
Correspondent Contact JEFF KLEIN
Regulation Number878.4800
Classification Product Code
GDM  
Date Received04/27/1988
Decision Date 12/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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