The following data is part of a premarket notification filed by Ahlstrom Nonwovens Llc with the FDA for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap.
| Device ID | K171533 |
| 510k Number | K171533 |
| Device Name: | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap |
| Classification | Wrap, Sterilization |
| Applicant | Ahlstrom Nonwovens LLC 2 Elm Street Windsor Locks, CT 06096 |
| Contact | Gary Jackson |
| Correspondent | Lauren Chrapowitzky AJW Technology Consultants, Inc 445 Apollo Beach Blvd Apollo Beach, FL 33572 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-25 |
| Decision Date | 2017-06-29 |
| Summary: | summary |