Eye Surgery Instrument

FDA 510(k) K840101 · Truline Instruments, Inc.

Substantially Equivalent

510(k) numberK840101

Submission

Device name
Eye Surgery Instrument
Applicant
Truline Instruments, Inc.
Mchenry, IL, US
Received
January 10, 1984
Decision date
March 16, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HOB – Clamp, Muscle, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Specialty
Ophthalmic

Other 510(k)s with product code HOB

510(k)DeviceApplicantDecision
K840310Category 6 Opthalmic DevicesHOB · Traditional Imm Enterprises , Ltd.03/16/1984SE
K780851Charles Endocoagulator Accessory for ArcHOB · Traditional Varian Assoc., Inc.06/30/1978SE

Questions and answers

When was Eye Surgery Instrument cleared by the FDA?

Eye Surgery Instrument (K840101) received a 510(k) decision of Substantially Equivalent on March 16, 1984, 66 days after the submission was received.

What is the product code of K840101?

The FDA product code is HOB – Clamp, Muscle, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.