510(k) K913273

DROLITE(TM) LIGHT SOURCE by Vision Medical, Inc. — Product Code HJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1991
Date Received
July 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transilluminator, Ac-Powered
Device Class
Class II
Regulation Number
886.1945
Review Panel
OP
Submission Type