Who is the manufacturer of DGH MODEL 9000?

Dgh Technology, Inc. submitted the Traditional clearance for DGH MODEL 9000 (K965127).

What is the FDA product code for DGH MODEL 9000?

HQC. It is classified under 21 CFR 886.4670 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for DGH MODEL 9000?

510(k) clearance (submission type: Traditional).

DGH MODEL 9000

K965127 · Dgh Technology, Inc. · HQC · Mar 17, 1997 · Ophthalmic

Device Facts

Record ID	K965127
Device Name	DGH MODEL 9000
Applicant	Dgh Technology, Inc.
Product Code	HQC · Ophthalmic
Decision Date	Mar 17, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4670
Device Class	Class 2

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.