The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Schroeder Endotracheal Tube Style.
Device ID | K955238 |
510k Number | K955238 |
Device Name: | RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE |
Classification | Stylet, Tracheal Tube |
Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
Contact | Neil R Armstrong |
Correspondent | Neil R Armstrong RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
Product Code | BSR |
CFR Regulation Number | 868.5790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-14 |
Decision Date | 1996-02-06 |