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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sterilant, medical devices
510(k) Number K932740
Device Name HOMEPUMP NSF
Applicant
BLOCK MEDICAL, INC.
5957 LANDAU COURT
CARLSBAD,  CA  92008
Applicant Contact IAN KENNEDY
Correspondent
BLOCK MEDICAL, INC.
5957 LANDAU COURT
CARLSBAD,  CA  92008
Correspondent Contact IAN KENNEDY
Regulation Number880.6885
Classification Product Code
MED  
Date Received06/08/1993
Decision Date 10/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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