The following data is part of a premarket notification filed by Castle Co. with the FDA for Modified Castle Powerclave.
| Device ID | K870975 |
| 510k Number | K870975 |
| Device Name: | MODIFIED CASTLE POWERCLAVE |
| Classification | Sterilizer, Steam |
| Applicant | CASTLE CO. SUITE 800 ONE THOMAS CIRCLE Washington, DC 20005 |
| Contact | Kurzman, Pc |
| Correspondent | Kurzman, Pc CASTLE CO. SUITE 800 ONE THOMAS CIRCLE Washington, DC 20005 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-10 |
| Decision Date | 1987-04-17 |