Modified Site Mobile Stand for Ophthalmic Use

Q: What is the product code of K883575?

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

FDA 510(k) K883575 · Site Microsurgical Systems, Inc.

Substantially Equivalent

510(k) numberK883575

Submission

Device name: Modified Site Mobile Stand for Ophthalmic Use
Applicant: Site Microsurgical Systems, Inc.
Horsham, PA, US
Received: August 22, 1988
Decision date: September 12, 1988
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)	Device	Applicant	Decision
K900161	A-Scan Roll-Around StandHMG · Traditional	Jedmed Instrument Co.	02/16/1990SE
K873554	Gorsk Instrument RestHMG · Traditional	Gorsk, Inc.	10/23/1987SE
K841759	Ophthalmic TableHMG · Traditional	Woodlyn, Inc.	06/01/1984SE

More from Woodlyn, Inc.

510(k)	Device	Decision
K925828	Modified Site TXR SystemsHQC · Traditional	02/16/1994SE
K925921	Modified Site Disposable Diaphragm CassetteKYG · Traditional	12/06/1993SE
K931866	Site's CD II Phacoemulsification HandpieceHQC · Traditional	11/12/1993SE
K921135	Iolab Power I.V. PoleHQC · Traditional	06/03/1992SE
K920582	180 Tip, 1/A Handpiece .3MM End Opening for Opht.HQE · Traditional	05/08/1992SE
K912902	Phacoemulsification System for Ophthalmic UseHQC · Traditional	12/17/1991SE
K912739	Site 90 Tip, I/A Handpiece .3MM Side Open/Opth UseHQC · Traditional	08/28/1991SE
K910980	Site 20 Gauge Reusable Fiber Optic CableHJO · Traditional	05/22/1991SE
K905620	Modified Site Peristaltic FootswitchEBW · Traditional	02/27/1991SE
K904183	Site Phacoemulsification HandpieceHQC · Traditional	12/05/1990SE

Questions and answers

When was Modified Site Mobile Stand for Ophthalmic Use cleared by the FDA?

Modified Site Mobile Stand for Ophthalmic Use (K883575) received a 510(k) decision of Substantially Equivalent on September 12, 1988, 21 days after the submission was received.

What is the product code of K883575?

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