FDA 510(k) Application Details - K022268

Device Classification Name Snare, Flexible

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510(K) Number K022268
Device Name Snare, Flexible
Applicant HORIZONS INTL. CORP.
P.O. BOX 7273
PONCE, PR 00732-7273 US
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Contact RAFIC SALEH
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Regulation Number 876.4300

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Classification Product Code FDI
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Date Received 07/15/2002
Decision Date 10/25/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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