Lopez-Horn Carrier

FDA 510(k) K831312 · Chiron Vision Corp.

Substantially Equivalent

510(k) numberK831312

Submission

Device name
Lopez-Horn Carrier
Applicant
Chiron Vision Corp.
Irvine, CA, US
Received
April 22, 1983
Decision date
May 25, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KYP – Snake Bite Suction Kit
Device class
Class I (low risk)
Regulation
21 CFR 880.5740
Specialty
General Hospital

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other 510(k)s with product code KYP

510(k)DeviceApplicantDecision
K883839Nd:Yag Laser Spectacles, MST Model #YLS-5KYP · Traditional Marlo Surgical Technology12/09/1988SE
K844048Dr. Hessel's Insect Poison RemoverKYP · Traditional Medie Group01/23/1985SE
K842015Sawyer First Aid KitKYP · Traditional Saffeta, Inc.07/06/1984SE

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K944993Iolab.Site CD Phacoemulsification ModuleHQC · Traditional 10/12/1995SE
K944995Iolab/Site Peristaltic ModuleHQC · Traditional 10/05/1995SE
K951292Passport Foldable Lens Placement SystemKYB · Traditional 06/02/1995SE
K944994Iolab/Site Disposable Diaphragm CassetteHQC · Traditional 03/14/1995SE
K941550Automatic Corneal Shaper Surgical InstrumentHNO · Traditional 11/22/1994SE
K935233Iolab Lacrimal Duct CatheterOKS · Traditional 09/15/1994SE
K925606Optical Zone/Hexagonal/Astigmatism/Radial MarkersHMR · Traditional 08/29/1994SE

Questions and answers

When was Lopez-Horn Carrier cleared by the FDA?

Lopez-Horn Carrier (K831312) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 33 days after the submission was received.

What is the product code of K831312?

The FDA product code is KYP – Snake Bite Suction Kit, a Class I (low risk) device regulated under 21 CFR 880.5740.