FDA 510(k) Application Details - K002236

Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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510(K) Number K002236
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant HORIZONS INTL. CORP.
200 POLITECNICA ST.
VILLAS UNIV. PO BOX 250435
AGUADILLA, PR 00604 US
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Contact RAFIC SALEH
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 07/24/2000
Decision Date 01/23/2001
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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