PROSPORE

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 Prospore.

Pre-market Notification Details

• Device ID: K971432
• 510k Number: K971432
• Device Name: PROSPORE
• Classification: Indicator, Biological Sterilization Process
• Applicant: RAVEN BIOLOGICAL LABORATORIES, INC. 5017 LEAVENWORTH ST. Omaha, NE 68106
• Contact: Kerrie Groff
• Correspondent: Kerrie Groff; RAVEN BIOLOGICAL LABORATORIES, INC. 5017 LEAVENWORTH ST. Omaha, NE 68106
• Product Code: FRC
• CFR Regulation Number: 880.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-04-17
• Decision Date: 1997-05-20
• Summary: summary