510(k) K840590

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

K840590 is an FDA 510(k) premarket notification submitted by Hgm, Inc. for the device "FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Hgm, Inc. has at least 10 other 510(k) clearances on record.

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