The following data is part of a premarket notification filed by Raven Biological Laboratories, Inc. with the FDA for Prospore2 Self-contained Biological Indicator.
| Device ID | K994381 |
| 510k Number | K994381 |
| Device Name: | PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | RAVEN BIOLOGICAL LABORATORIES, INC. 8607 PARK DR. Omaha, NE 68127 |
| Contact | Wendy Royalty |
| Correspondent | Wendy Royalty 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 | 1999-12-28 |
| Decision Date | 2001-03-30 |
| Summary: | summary |