SPOROX

Sterilant, Medical Devices

RECKITT BENCKISER, INC.

The following data is part of a premarket notification filed by Reckitt Benckiser, Inc. with the FDA for Sporox.

Pre-market Notification Details

• Device ID: K970230
• 510k Number: K970230
• Device Name: SPOROX
• Classification: Sterilant, Medical Devices
• Applicant: RECKITT BENCKISER, INC. ONE PHILIPS PKWY. Montvale, NJ 07645 -1575
• Contact: Eileen J Moyer
• Correspondent: Eileen J Moyer; RECKITT BENCKISER, INC. ONE PHILIPS PKWY. Montvale, NJ 07645 -1575
• Product Code: MED
• CFR Regulation Number: 880.6885 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-01-21
• Decision Date: 1997-10-29
• Summary: summary