The following data is part of a premarket notification filed by Fort Defiance Industries, Inc. with the FDA for Fort Defiance Automated Steam Sterilizer.
| Device ID | K141009 |
| 510k Number | K141009 |
| Device Name: | FORT DEFIANCE AUTOMATED STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | Fort Defiance Industries, Inc. 155 B Natalie BLVD Loudon, TN 37774 |
| Contact | Chris Yerger |
| Correspondent | Chris Yerger Fort Defiance Industries, Inc. 155 B Natalie BLVD Loudon, TN 37774 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-18 |
| Decision Date | 2014-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862992000334 | K141009 | 000 |
| 00862992000327 | K141009 | 000 |
| 00862992000310 | K141009 | 000 |
| 00862992000303 | K141009 | 000 |