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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K022243
Device Name HORIZONS REUSABLE HOT BIOPSY FORCEPS
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 Number876.4300
Classification Product Code
KGE  
Date Received07/12/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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