The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Midmark M9 Ultraclave Steam Sterilizer.
| Device ID | K023348 |
| 510k Number | K023348 |
| Device Name: | MIDMARK M9 ULTRACLAVE STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
| Contact | Gene Jarshnarger |
| Correspondent | Gene Jarshnarger 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 | 2002-10-07 |
| Decision Date | 2003-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709100208 | K023348 | 000 |
| 00841709100154 | K023348 | 000 |
| 00841709100093 | K023348 | 000 |
| 00841709100086 | K023348 | 000 |
| 00841709100079 | K023348 | 000 |
| 00841709100062 | K023348 | 000 |
| 00841709100055 | K023348 | 000 |
| 00841709100048 | K023348 | 000 |