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 |