The following data is part of a premarket notification filed by Andersen Sterilizers, Inc. with the FDA for Tyvek Sterilization Pouches With Chevron Seal.
| Device ID | K170429 |
| 510k Number | K170429 |
| Device Name: | Tyvek Sterilization Pouches With Chevron Seal |
| Classification | Wrap, Sterilization |
| 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 | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-13 |
| Decision Date | 2017-10-27 |
| Summary: | summary |