The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Luer, Jackson Trachea Tubes, Luer Speaking Trachea Tubes.
| Device ID | K953368 |
| 510k Number | K953368 |
| Device Name: | LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Renate A Maclaren |
| Correspondent | Renate A Maclaren KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-18 |
| Decision Date | 1995-09-18 |