FDA 510(k) Application Details - K874312

Device Classification Name Catheter, Urological

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510(K) Number K874312
Device Name Catheter, Urological
Applicant ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD, NJ US
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Contact BERNARD ACKERMAN
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Regulation Number 876.5130

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Classification Product Code KOD
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Date Received 10/20/1987
Decision Date 12/29/1987
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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