FDA 510(k) Application Details - K011667

Device Classification Name Snare, Flexible

  More FDA Info for this Device
510(K) Number K011667
Device Name Snare, Flexible
Applicant HORIZONS INTL. CORP.
P.O. BOX 7273
PONCE, PR 00732-7273 US
Other 510(k) Applications for this Company
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 05/30/2001
Decision Date 08/16/2001
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact