510(k) K923555

CODMAN GAAB NEUROENDOSCOPE by Codman & Shurtleff, Inc. — Product Code GWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1993
Date Received
July 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type