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FDA 510(k) Application Details - K022546
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K022546
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
HORIZONS INTL. CORP.
287 MONTERREY ST.
P.O.BOX 7273
PONCE, PR 00717 US
Other 510(k) Applications for this Company
Contact
RAFIC SALEH
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2002
Decision Date
08/12/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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