The following data is part of a premarket notification filed by Sterilucent, Inc with the FDA for Sterilucent Sterilization Container System.
| Device ID | K142109 |
| 510k Number | K142109 |
| Device Name: | STERILUCENT STERILIZATION CONTAINER SYSTEM |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| 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 | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2015-01-20 |
| Summary: | summary |