The following data is part of a premarket notification filed by Getinge/castle, Inc. with the FDA for Castle Series 200 Steam Sterilizer (powerclave).
| Device ID | K973225 |
| 510k Number | K973225 |
| Device Name: | CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) |
| Classification | Sterilizer, Steam |
| Applicant | GETINGE/CASTLE, INC. 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Contact | Michael J Palladino |
| Correspondent | Gordon Gillerman UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1997-08-27 |
| Decision Date | 1998-02-10 |
| Summary: | summary |