FDA 510(k) Application Details - K973593

Device Classification Name Pump, Infusion

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510(K) Number K973593
Device Name Pump, Infusion
Applicant BRIDGE MEDICAL, INC.
265 SANTA HELENA SUITE 210
SOLONA BEACH, CA US
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Contact DONALD V CANAL
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 09/22/1997
Decision Date 08/25/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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