Cleared Traditional

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)

K860358 · Hgm, Inc. · Ophthalmic

Mar 1986

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K860358 is an FDA 510(k) clearance for the FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE), a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 21, 1986, 50 days after receiving the submission on January 30, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K860358 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1986
Decision Date	March 21, 1986
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—