FDA 510(k) Application Details - K972372

Device Classification Name Catheter And Tip, Suction

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510(K) Number K972372
Device Name Catheter And Tip, Suction
Applicant RZV MEDICAL SPECIALTIES, INC.
34 THORNCREST DR.
PITTSBURGH, PA 15235 US
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Contact LINDA K RUVO
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Regulation Number 880.6740

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Classification Product Code JOL
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Date Received 06/25/1997
Decision Date 12/11/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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