FDA 510(k) Application Details - K051370

Device Classification Name Catheter And Tip, Suction

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510(K) Number K051370
Device Name Catheter And Tip, Suction
Applicant BAXTER HEALTHCARE CORP.
1620 WAUKEGAN RD., MPGR-AL
MCGAW PARK, IL 60085 US
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Contact NANETTE HEDDEN
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Regulation Number 880.6740

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Classification Product Code JOL
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Date Received 05/26/2005
Decision Date 08/12/2005
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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