The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rush Oral/nasal Tracheal Tube Cuffed Magill/murphy.
Device ID | K961837 |
510k Number | K961837 |
Device Name: | RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
Contact | Karenann J Brozowski |
Correspondent | Karenann J Brozowski RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-13 |
Decision Date | 1996-08-16 |
Summary: | summary |