510(k) K021931

ENDOSCOPIC FIBEROPTIC CABLE by Gulf Medical Fiberoptics — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2002
Date Received
June 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type