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FDA 510(k) Application Details - K022268
Device Classification Name
Snare, Flexible
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
FDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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