Gorsk Instrument Rest

FDA 510(k) K873554 · Gorsk, Inc.

Substantially Equivalent

510(k) numberK873554

Submission

Device name
Gorsk Instrument Rest
Applicant
Gorsk, Inc.
Camarillo, CA, US
Received
August 28, 1987
Decision date
October 23, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HMG – Stand, Instrument, Ophthalmic, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.1860
Specialty
Ophthalmic

Other 510(k)s with product code HMG

510(k)DeviceApplicantDecision
K900161A-Scan Roll-Around StandHMG · Traditional Jedmed Instrument Co.02/16/1990SE
K883575Modified Site Mobile Stand for Ophthalmic UseHMG · Traditional Site Microsurgical Systems, Inc.09/12/1988SE
K841759Ophthalmic TableHMG · Traditional Woodlyn, Inc.06/01/1984SE

More from Woodlyn, Inc.

510(k)DeviceDecision
K873555Gorsk Sponge Containment SystemLWH · Traditional 10/23/1987SE

Questions and answers

When was Gorsk Instrument Rest cleared by the FDA?

Gorsk Instrument Rest (K873554) received a 510(k) decision of Substantially Equivalent on October 23, 1987, 56 days after the submission was received.

What is the product code of K873554?

The FDA product code is HMG – Stand, Instrument, Ophthalmic, Non-Powered, a Class I (low risk) device regulated under 21 CFR 886.1860.