The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Modification Of: Midmark M-11 Ultraclave Steam Sterilizer.
| Device ID | K990189 |
| 510k Number | K990189 |
| Device Name: | MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
| Contact | James Rile |
| Correspondent | James Rile 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 | 1999-01-20 |
| Decision Date | 1999-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709100178 | K990189 | 000 |
| 00841709100147 | K990189 | 000 |
| 00841709100130 | K990189 | 000 |
| 00841709100123 | K990189 | 000 |
| 00841709100116 | K990189 | 000 |
| 00841709100109 | K990189 | 000 |