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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 K944692
Device Name C-SERIES HOMEPUMP
Applicant
Block Medical, Inc.
5957 Landau Ct.
Carlsbad,  CA  92008
Applicant Contact ROBERT J BARD
Correspondent
Block Medical, Inc.
5957 Landau Ct.
Carlsbad,  CA  92008
Correspondent Contact ROBERT J BARD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/23/1994
Decision Date 05/02/1995
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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