The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Model #m9 Ultraclave Steam Sterilizer.
| Device ID | K911322 |
| 510k Number | K911322 |
| Device Name: | MODEL #M9 ULTRACLAVE STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
| Contact | John Oldiges |
| Correspondent | John Oldiges MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-26 |
| Decision Date | 1991-08-26 |