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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K022546
Device Name HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
Applicant
Horizons Intl. Corp.
287 Monterrey St.
P.O.Box 7273
Ponce,  PR  00717
Applicant Contact RAFIC SALEH
Correspondent
Horizons Intl. Corp.
287 Monterrey St.
P.O.Box 7273
Ponce,  PR  00717
Correspondent Contact RAFIC SALEH
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received08/01/2002
Decision Date 08/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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