Cleared Traditional

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE

K840590 · Hgm, Inc. · Ophthalmic

May 1984

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K840590 is an FDA 510(k) clearance for the FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Hgm, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984, 90 days after receiving the submission on February 9, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K840590 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 1984
Decision Date	May 09, 1984
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—