The following data is part of a premarket notification filed by Fort Defiance Industries Llc with the FDA for Fort Defiance Industries Front-line Field Sterilizer Fl120, Fort Defiance Industries Front-line Field Sterilizer Fl135.
| Device ID | K213457 |
| 510k Number | K213457 |
| Device Name: | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 |
| Classification | Sterilizer, Steam |
| Applicant | Fort Defiance Industries LLC 2411 Maremont Parkway Loudon, TN 37774 |
| Contact | Chris Coleman |
| Correspondent | Chris Coleman Fort Defiance Industries LLC 2411 Maremont Parkway Loudon, TN 37774 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-27 |
| Decision Date | 2022-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862992000341 | K213457 | 000 |
| 00862992000358 | K213457 | 000 |