PALA-NATE
Tube, Tracheal (w/wo Connector)
GESCO INTL., INC.
The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Pala-nate.
Pre-market Notification Details
| Device ID | K923591 |
| 510k Number | K923591 |
| Device Name: | PALA-NATE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Contact | Jame K Klein |
| Correspondent | Jame K Klein GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-20 |
| Decision Date | 1993-03-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67140050000 | K923591 | 000 |
| H67140030001 | K923591 | 000 |
| H67140025001 | K923591 | 000 |
| H67140020001 | K923591 | 000 |
| H67140015001 | K923591 | 000 |
Trademark Results [PALA-NATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PALA-NATE 74713788 2186181 Live/Registered |
UTAH MEDICAL PRODUCTS, INC. 1995-08-10 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.