FDA 510(k) Application Details - K021813

Device Classification Name Lavage, Jet

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510(K) Number K021813
Device Name Lavage, Jet
Applicant HYDROCISION, INC.
7 TIFFANY TRAIL
HOPKINTON, MA 01748 US
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Contact DEBBIE IAMPIETRO
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Regulation Number 880.5475

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Classification Product Code FQH
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Date Received 06/03/2002
Decision Date 05/09/2003
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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