The following data is part of a premarket notification filed by Raven Biological Laboratories, Inc. with the FDA for Prospore(stearo For Steam Sterilizer).
| Device ID | K962441 |
| 510k Number | K962441 |
| Device Name: | PROSPORE(STEARO FOR STEAM STERILIZER) |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | RAVEN BIOLOGICAL LABORATORIES, INC. P.O. BOX 6408 5017 LEAVENWORTH ST. Omaha, NE 68106 |
| Contact | Kerrie Groff |
| Correspondent | Kerrie Groff RAVEN BIOLOGICAL LABORATORIES, INC. P.O. BOX 6408 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 | 1996-06-24 |
| Decision Date | 1996-09-18 |
| Summary: | summary |