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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K864276
Device Name PERSONAL INFUSION PUMP
Applicant
Bionica, Inc.
49 Gumnut Rd.
Cherrybrook
Nsw 2120 Australia,  AU
Applicant Contact VLADIMIR FEINGOLD
Correspondent
Bionica, Inc.
49 Gumnut Rd.
Cherrybrook
Nsw 2120 Australia,  AU
Correspondent Contact VLADIMIR FEINGOLD
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/29/1986
Decision Date 03/17/1987
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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