The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Oral/nasal (safety Clear Plus) Tracheal Tube Cuffed, Magill/murphy.
Device ID | K993786 |
510k Number | K993786 |
Device Name: | RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) 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 | 1999-11-08 |
Decision Date | 2000-02-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
44026704341694 | K993786 | 000 |
44026704341687 | K993786 | 000 |
24026704341676 | K993786 | 000 |
24026704341669 | K993786 | 000 |
44026704341526 | K993786 | 000 |
24026704341515 | K993786 | 000 |
44026704341502 | K993786 | 000 |
24026704341492 | K993786 | 000 |