The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Sheridan/hvt,cf, Uncuffed.
Device ID | K822082 |
510k Number | K822082 |
Device Name: | SHERIDAN/HVT,CF, UNCUFFED |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | SHERIDAN CATHETER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-12 |
Decision Date | 1982-08-10 |