NPH-KLENZ

Cleaner, Ultrasonic, Medical Instrument

CALGON CORP.

The following data is part of a premarket notification filed by Calgon Corp. with the FDA for Nph-klenz.

Pre-market Notification Details

• Device ID: K940263
• 510k Number: K940263
• Device Name: NPH-KLENZ
• Classification: Cleaner, Ultrasonic, Medical Instrument
• Applicant: CALGON CORP. SUB. MERCK & CO., INC. 5035 MANCHESTER AVE. St. Louis, MO 63110
• Contact: Michael Ebers
• Correspondent: Michael Ebers; CALGON CORP. SUB. MERCK & CO., INC. 5035 MANCHESTER AVE. St. Louis, MO 63110
• Product Code: FLG
• CFR Regulation Number: 880.6150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-01-21
• Decision Date: 1994-05-18