The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Polyflex Stent Kit.
Device ID | K013266 |
510k Number | K013266 |
Device Name: | RUSCH POLYFLEX STENT KIT |
Classification | Prosthesis, Tracheal, Expandable, Polymeric |
Applicant | RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
Contact | Karenann J Brozowski |
Correspondent | Karenann J Brozowski RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
Product Code | NYT |
CFR Regulation Number | 878.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-01 |
Decision Date | 2001-11-27 |
Summary: | summary |