FDA 510(k) Application Details - K041464

Device Classification Name Catheter, Straight

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510(K) Number K041464
Device Name Catheter, Straight
Applicant BUSSE HOSPITAL DISPOSABLES
PO BOX 11067
HAUPPAUGE, NY 11788 US
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Contact MUHAMAD ANSARI
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Regulation Number 876.5130

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Classification Product Code EZD
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Date Received 06/02/2004
Decision Date 11/05/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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