The following data is part of a premarket notification filed by Fiberweb North America, Inc. with the FDA for Sterisure Sterilization Wrap.
| Device ID | K944854 |
| 510k Number | K944854 |
| Device Name: | STERISURE STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | FIBERWEB NORTH AMERICA, INC. 840 SOUTH EAST MAIN ST. Simpsonville, SC 29681 |
| Contact | Cornelius A Cunningham |
| Correspondent | Cornelius A Cunningham FIBERWEB NORTH AMERICA, INC. 840 SOUTH EAST MAIN ST. Simpsonville, SC 29681 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-30 |
| Decision Date | 1994-12-19 |