The following data is part of a premarket notification filed by Sterilucent, Inc. with the FDA for Sterilucent Hc 80tt Hydrogen Peroxide Sterilizer.
| Device ID | K190005 |
| 510k Number | K190005 |
| Device Name: | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer |
| Classification | Sterilizer, Chemical |
| Applicant | Sterilucent, Inc. 1400 Marshall St. NE Minneapolis, MN 55413 |
| Contact | Peter Kalkbrenner |
| Correspondent | Peter Kalkbrenner Sterilucent, Inc. 1400 Marshall St. NE Minneapolis, MN 55413 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-02 |
| Decision Date | 2019-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850012210009 | K190005 | 000 |