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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K023323
Device Name 1CC FUTURA SAFETY SYRINGE
Applicant
Futura Medical Technology
380 Stevens Ave., Suite 212
Solana Beach,  CA  92075
Applicant Contact DAVID OLMSTEAD
Correspondent
Futura Medical Technology
380 Stevens Ave., Suite 212
Solana Beach,  CA  92075
Correspondent Contact DAVID OLMSTEAD
Regulation Number880.5860
Classification Product Code
MEG  
Date Received10/04/2002
Decision Date 10/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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