510(k) K931784

HGM ILLUMINATING IMAGING ENDOCULAR PROBE by Hgm, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1994
Date Received
April 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type