FDA 510(k) Application Details - K974568

Device Classification Name Lavage, Jet

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510(K) Number K974568
Device Name Lavage, Jet
Applicant CHASE MEDICAL, INC.
1876 FIRMAN DR.
RICHARDSON, TX 75081 US
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Contact BERT DAVIS
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Regulation Number 880.5475

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Classification Product Code FQH
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Date Received 12/05/1997
Decision Date 01/06/1998
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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