510(k) K061025

ACCUTECH ENDOLITE PROBE by Accutech Medical Technologies, Inc. — Product Code FFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2006
Date Received
April 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type