The following data is part of a premarket notification filed by Andersen Sterilizers, Inc. with the FDA for Sterisheet Sterilization Wrap.
| Device ID | K152291 |
| 510k Number | K152291 |
| Device Name: | Sterisheet Sterilization Wrap |
| 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 | 2015-08-13 |
| Decision Date | 2015-12-17 |
| Summary: | summary |