510(k) K971377

GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE by Wilson Greatbatch Technologies, Inc. — Product Code CCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1998
Date Received
April 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Rigid
Device Class
Class I
Regulation Number
868.5540
Review Panel
AN
Submission Type