The following data is part of a premarket notification filed by Wagner Gmbh with the FDA for Wagner Steriset Sterilization Container.
Device ID | K041096 |
510k Number | K041096 |
Device Name: | WAGNER STERISET STERILIZATION CONTAINER |
Classification | Wrap, Sterilization |
Applicant | WAGNER GMBH 22411 60TH STREET Bristol, WI 53104 |
Contact | Lara N Simmons |
Correspondent | Lara N Simmons WAGNER GMBH 22411 60TH STREET Bristol, WI 53104 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-27 |
Decision Date | 2005-06-03 |
Summary: | summary |