The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Midmark M3 Ultrafast Automatic Sterilizer.
| Device ID | K090670 |
| 510k Number | K090670 |
| Device Name: | MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
| Contact | Gary Benning |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-03-13 |
| Decision Date | 2009-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709100192 | K090670 | 000 |
| 00841709100031 | K090670 | 000 |
| 00841709100024 | K090670 | 000 |
| 00841709100017 | K090670 | 000 |
| 00841709100000 | K090670 | 000 |
| 00841709109584 | K090670 | 000 |
| 00841709109577 | K090670 | 000 |
| 00841709109560 | K090670 | 000 |
| 00841709109591 | K090670 | 000 |