The following data is part of a premarket notification filed by Wolfe Tory Medical, Inc. with the FDA for Madett.
Device ID | K021044 |
510k Number | K021044 |
Device Name: | MADETT |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | WOLFE TORY MEDICAL, INC. 79 WEST 4500 SOUTH, SUITE 16 Salt Lake City, UT 84107 |
Contact | Tim Wolfe |
Correspondent | Tim Wolfe WOLFE TORY MEDICAL, INC. 79 WEST 4500 SOUTH, SUITE 16 Salt Lake City, UT 84107 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-01 |
Decision Date | 2002-09-11 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MADETT 85299039 4172723 Dead/Cancelled |
Wolfe Tory Medical, Inc. 2011-04-19 |