510(k) K840590

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE by Hgm, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
February 9, 1984
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