The following data is part of a premarket notification filed by Getinge/castle, Inc. with the FDA for Castle Peracetic Acid Biological Indicator Kit.
| Device ID | K020205 |
| 510k Number | K020205 |
| Device Name: | CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | GETINGE/CASTLE, INC. 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Contact | Mark N Smith |
| Correspondent | Mark N Smith GETINGE/CASTLE, INC. 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-22 |
| Decision Date | 2002-06-24 |
| Summary: | summary |