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510(k) K873554

GORSK INSTRUMENT REST by Gorsk, Inc. — Product Code HMG

K873554 is an FDA 510(k) premarket notification submitted by Gorsk, Inc. for the device "GORSK INSTRUMENT REST". The FDA issued a decision of Substantially Equivalent on October 23, 1987. The device falls under product code HMG (Stand, Instrument, Ophthalmic, Non-Powered), a Class I device regulated under 21 CFR 886.1860. Gorsk, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
August 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Instrument, Ophthalmic, Non-Powered
Device Class
Class I
Regulation Number
886.1860
Review Panel
OP
Submission Type

Other clearances by Gorsk, Inc.

  • K873555 — GORSK SPONGE CONTAINMENT SYSTEM (October 23, 1987)

Other clearances for product code HMG

  • K900161 — A-SCAN ROLL-AROUND STAND (February 16, 1990)
  • K883575 — MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE (September 12, 1988)
  • K841759 — OPHTHALMIC TABLE (June 1, 1984)

FDA data resources