FDA 510(k) Application Details - K022558

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K022558
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant MEDICAL INNOVATIVE PRODUCTS
7 TIFFANY TRAIL
HOPKINTON, MA 01748 US
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Contact DEBBIE IAMPIETRO
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 08/02/2002
Decision Date 07/08/2003
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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