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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K854563
Device Name DISPOSABLE SYRINGES & NEEDLES
Applicant
Medelec Intl. Corp.
One Lincoln Rd., Suite 304
Miami Beach,  FL  33139
Applicant Contact OSCAR D DOCAL
Correspondent
Medelec Intl. Corp.
One Lincoln Rd., Suite 304
Miami Beach,  FL  33139
Correspondent Contact OSCAR D DOCAL
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/14/1985
Decision Date 12/09/1985
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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