Nph-Klenz

FDA 510(k) K940263 · Calgon Corp.

Substantially Equivalent

510(k) numberK940263

Submission

Device name
Nph-Klenz
Applicant
Calgon Corp.
St. Louis, MO, US
Received
January 21, 1994
Decision date
May 18, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FLG – Cleaner, Ultrasonic, Medical Instrument
Device class
Class I (low risk)
Regulation
21 CFR 880.6150
Specialty
General Hospital

Other 510(k)s with product code FLG

510(k)DeviceApplicantDecision
K944950KlenzymeFLG · Traditional Calgon Corp.12/20/1994SE
K944494Alsa-KlenzFLG · Traditional Calgon Vestal Div.10/19/1994SE
K944033Bill Evans-KlenzFLG · Traditional Calgon Vestal Div.10/07/1994SE
K941163Mon-KlenzFLG · Traditional Calgon Vestal Div.05/18/1994SE
K935063Instru KlenzFLG · Traditional Calgon Corp.05/09/1994SE
K934666PDS UltracleanFLG · Traditional Medical Polymers, Inc.04/15/1994SE
K931270Surgiclean Enzymatic Instrument CleanerFLG · Traditional Surgicot, Inc.04/13/1994SE
K933149Instrument Detergent ConcentrateFLG · Traditional Nobelpharma USA, Inc.02/16/1994SE
K884660Biosonic Ultrasonic Cleaning SystemFLG · Traditional Whaledent Intl. Div. Ipco03/16/1989SE
K862282Rapidex Biological SurfactantFLG · Traditional Rapidex of London05/11/1987SE

More from Rapidex of London

510(k)DeviceDecision
K944950KlenzymeFLG · Traditional 12/20/1994SE
K943364Corassist Wound DressingKMF · Traditional 08/03/1994SE
K935063Instru KlenzFLG · Traditional 05/09/1994SE
K940407Kaltogel Wound DressingKMF · Traditional 04/07/1994SN

Questions and answers

When was Nph-Klenz cleared by the FDA?

Nph-Klenz (K940263) received a 510(k) decision of Substantially Equivalent on May 18, 1994, 117 days after the submission was received.

What is the product code of K940263?

The FDA product code is FLG – Cleaner, Ultrasonic, Medical Instrument, a Class I (low risk) device regulated under 21 CFR 880.6150.