The following data is part of a premarket notification filed by Andersen Sterilizers, Inc. with the FDA for Anprolene An75 Ethylene Oxide Gas Sterilizer.
| Device ID | K170432 |
| 510k Number | K170432 |
| Device Name: | Anprolene AN75 Ethylene Oxide Gas Sterilizer |
| Classification | Sterilizer, Ethylene-oxide Gas |
| Applicant | Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258 |
| Contact | William K. Andersen |
| Correspondent | William K. Andersen Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258 |
| Product Code | FLF |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-13 |
| Decision Date | 2017-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060485030669 | K170432 | 000 |
| 05060485030638 | K170432 | 000 |
| 05060485030621 | K170432 | 000 |
| 05060485030614 | K170432 | 000 |
| 05060485030607 | K170432 | 000 |