510(k) K883858

FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE by Advanced Surgical Products, Inc. — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1988
Date Received
September 13, 1988
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