The following data is part of a premarket notification filed by Merlyn Associates Inc. with the FDA for Endoflex Tracheal Tube.
| Device ID | K031794 |
| 510k Number | K031794 |
| Device Name: | ENDOFLEX TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MERLYN ASSOCIATES INC. AMSINO INTERNATIONAL INC. 4501 BRICKELL PRIVADO Ontario, CA 91761 |
| Contact | Ching Ching Seah, Ph.d. |
| Correspondent | Ching Ching Seah, Ph.d. MERLYN ASSOCIATES INC. AMSINO INTERNATIONAL INC. 4501 BRICKELL PRIVADO Ontario, CA 91761 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-10 |
| Decision Date | 2004-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10182151000584 | K031794 | 000 |
| 00182151000556 | K031794 | 000 |
| 10182151000546 | K031794 | 000 |
| 10182151000539 | K031794 | 000 |