MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS

Indicator, Biological Sterilization Process

RAVEN BIOLOGICAL LABORATORIES, INC.

The following data is part of a premarket notification filed by Raven Biological Laboratories, Inc. with the FDA for Modification To:raven Bacterial Spore Strips.

Pre-market Notification Details

• Device ID: K032914
• 510k Number: K032914
• Device Name: MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
• Classification: Indicator, Biological Sterilization Process
• Applicant: RAVEN BIOLOGICAL LABORATORIES, INC. 8607 PARK DR. Omaha, NE 68127
• Contact: Wendy Royalty-hann
• Correspondent: Wendy Royalty-hann; RAVEN BIOLOGICAL LABORATORIES, INC. 8607 PARK DR. Omaha, NE 68127
• Product Code: FRC
• CFR Regulation Number: 880.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-22
• Decision Date: 2004-05-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850065007496	K032914	000
00850065007489	K032914	000