The following data is part of a premarket notification filed by Getinge/castle, Inc. with the FDA for Castle Series 100hc Steam Sterilizers.
| Device ID | K994314 |
| 510k Number | K994314 |
| Device Name: | CASTLE SERIES 100HC STEAM STERILIZERS |
| Classification | Sterilizer, Steam |
| 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 | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-02-16 |
| Summary: | summary |