The following data is part of a premarket notification filed by Thomas Medical Products, Inc. with the FDA for Y-glide.
Device ID | K072745 |
510k Number | K072745 |
Device Name: | Y-GLIDE |
Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
Applicant | THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355 |
Contact | Tim Stoudt |
Correspondent | Tim Stoudt THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355 |
Product Code | DTL |
CFR Regulation Number | 870.4290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-27 |
Decision Date | 2008-01-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
Y-GLIDE 77169341 3740377 Dead/Cancelled |
Thomas Medical Products, Inc. 2007-04-30 |
Y-GLIDE 75373145 2227724 Dead/Cancelled |
Trek Bicycle Corporation 1997-10-15 |