The following data is part of a premarket notification filed by Raven Biological Laboratories, Inc. with the FDA for Prospore Ii.
| Device ID | K971430 |
| 510k Number | K971430 |
| Device Name: | PROSPORE II |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | RAVEN BIOLOGICAL LABORATORIES, INC. 5017 LEAVENWORTH ST. Omaha, NE 68106 |
| Contact | Russ Nyberg |
| Correspondent | Russ Nyberg 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 | 1997-05-22 |
| Summary: | summary |