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.
| 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 |