The following data is part of a premarket notification filed by Mdt Biologic Co. with the FDA for Mdt/castle Models S-8 Table Top Steam Sterilizer.
| Device ID | K910777 |
| 510k Number | K910777 |
| Device Name: | MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | MDT BIOLOGIC CO. 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester, NY 14692 |
| Contact | Mark N Smith |
| Correspondent | Mark N Smith MDT BIOLOGIC CO. 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester, NY 14692 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-22 |
| Decision Date | 1992-03-27 |