FDA 510(k) Application Details - K022546

Device Classification Name Bronchoscope (Flexible Or Rigid)

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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
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Contact RAFIC SALEH
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Regulation Number 874.4680

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Classification Product Code EOQ
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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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