The following data is part of a premarket notification filed by Andersen Sterilizers, Inc. with the FDA for An85/an86 Eo Indicators.
| Device ID | K150644 |
| 510k Number | K150644 |
| Device Name: | AN85/AN86 EO Indicators |
| Classification | Indicator, Physical/chemical Sterilization Process |
| 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 | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-12 |
| Decision Date | 2015-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060485030270 | K150644 | 000 |
| 05060485030263 | K150644 | 000 |