510(k) K860358

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

K860358 is an FDA 510(k) premarket notification submitted by Hgm, Inc. for the device "FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)". The FDA issued a decision of Substantially Equivalent on March 21, 1986. 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.