510(k) K002236

HORIZONS PAPILLOTOME by Horizons Intl. Corp. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2001
Date Received
July 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type