The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Tracheal Tube W/airway Intubator.
Device ID | K844746 |
510k Number | K844746 |
Device Name: | TRACHEAL TUBE W/AIRWAY INTUBATOR |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Contact | John A Steen |
Correspondent | John A Steen SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-06 |
Decision Date | 1985-01-14 |