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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 K923321
Device Name EDGE SYRINGES AND NEEDLES
Applicant
Trico Intl., Inc.
401 Broadway
Suite 606
New York,  NY  10013
Applicant Contact ESTHER LAI
Correspondent
Trico Intl., Inc.
401 Broadway
Suite 606
New York,  NY  10013
Correspondent Contact ESTHER LAI
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received07/07/1992
Decision Date 09/28/1993
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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