510(k) K973293

SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR by Vaughan Weeks — Product Code MPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1997
Date Received
September 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type