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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K881390
Device Name NEEDLE SHIELD NEEDLE DISPOSAL UNIT
Applicant
Xenetics Biomedical, Inc.
4330 Barranca Pkwy.
Suite 101/364
Irvine,  CA  92714
Applicant Contact JOSEPH A FANELLI
Correspondent
Xenetics Biomedical, Inc.
4330 Barranca Pkwy.
Suite 101/364
Irvine,  CA  92714
Correspondent Contact JOSEPH A FANELLI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/04/1988
Decision Date 04/29/1988
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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