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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 K904382
Device Name SAFE-T-STIK
Applicant
Xikon Technology
255 Ruby Ave.
San Carlos,  CA  94070
Applicant Contact WALTER ENGLERT
Correspondent
Xikon Technology
255 Ruby Ave.
San Carlos,  CA  94070
Correspondent Contact WALTER ENGLERT
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/26/1990
Decision Date 10/17/1990
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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