The following data is part of a premarket notification filed by Midmark Corporation with the FDA for Midmark And Ritter M9 And M11 Ultraclave® Automatic Sterilizers And Ritter M9d Autoclave® Automatic Sterilizer.
| Device ID | K163337 |
| 510k Number | K163337 |
| Device Name: | Midmark And Ritter M9 And M11 UltraClave® Automatic Sterilizers And Ritter M9D AutoClave® Automatic Sterilizer |
| Classification | Sterilizer, Steam |
| Applicant | Midmark Corporation 60 VISTA DR. Versailles, OH 45380 |
| Contact | Adam Clutter |
| Correspondent | Adam Clutter Midmark Corporation 60 VISTA DR. 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 | 2016-11-28 |
| Decision Date | 2017-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709100307 | K163337 | 000 |
| 00841709118180 | K163337 | 000 |
| 00841709118173 | K163337 | 000 |
| 00841709118159 | K163337 | 000 |
| 00841709118142 | K163337 | 000 |
| 00841709118135 | K163337 | 000 |
| 00841709100291 | K163337 | 000 |
| 00841709100284 | K163337 | 000 |
| 00841709100246 | K163337 | 000 |
| 00841709100239 | K163337 | 000 |
| 00841709100277 | K163337 | 000 |
| 00841709118197 | K163337 | 000 |
| 00841709118210 | K163337 | 000 |
| 00841709100260 | K163337 | 000 |
| 00841709100314 | K163337 | 000 |
| 00841709100253 | K163337 | 000 |
| 00841709118319 | K163337 | 000 |
| 00841709118296 | K163337 | 000 |
| 00841709118289 | K163337 | 000 |
| 00841709118272 | K163337 | 000 |
| 00841709118241 | K163337 | 000 |
| 00841709118234 | K163337 | 000 |
| 00841709118227 | K163337 | 000 |
| 00841709100222 | K163337 | 000 |