The following data is part of a premarket notification filed by Getinge Usa, Inc with the FDA for Spor-test Pa Biological Indicator Kit.
| Device ID | K050664 |
| 510k Number | K050664 |
| Device Name: | SPOR-TEST PA BIOLOGICAL INDICATOR KIT |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | GETINGE USA, INC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Contact | Bard Smith |
| Correspondent | Bard Smith GETINGE USA, INC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-15 |
| Decision Date | 2005-04-07 |
| Summary: | summary |