The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Tracheal Bronchial Y Stent.
Device ID | K953593 |
510k Number | K953593 |
Device Name: | RUSCH TRACHEAL BRONCHIAL Y STENT |
Classification | Prosthesis, Tracheal, Expandable, Polymeric |
Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
Contact | Karenann J Brozowski |
Correspondent | Karenann J Brozowski RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
Product Code | NYT |
CFR Regulation Number | 878.3720 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-31 |
Decision Date | 1995-10-13 |
Summary: | summary |