The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Insulated Cannulae, Suction Tubes.
| Device ID | K944797 |
| 510k Number | K944797 |
| Device Name: | KARL STORZ INSULATED CANNULAE, SUCTION TUBES |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-28 |
| Decision Date | 1994-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551213698 | K944797 | 000 |
| 04048551195413 | K944797 | 000 |
| 04048551195406 | K944797 | 000 |
| 04048551048399 | K944797 | 000 |
| 04048551048382 | K944797 | 000 |
| 04048551048375 | K944797 | 000 |
| 04048551048368 | K944797 | 000 |
| 04048551213537 | K944797 | 000 |
| 04048551213513 | K944797 | 000 |
| 04048551213445 | K944797 | 000 |
| 04048551213421 | K944797 | 000 |
| 04048551207727 | K944797 | 000 |
| 04048551207734 | K944797 | 000 |
| 04048551207765 | K944797 | 000 |
| 04048551213681 | K944797 | 000 |
| 04048551213674 | K944797 | 000 |
| 04048551213667 | K944797 | 000 |
| 04048551213650 | K944797 | 000 |
| 04048551213643 | K944797 | 000 |
| 04048551213636 | K944797 | 000 |
| 04048551213629 | K944797 | 000 |
| 04048551213612 | K944797 | 000 |
| 04048551213605 | K944797 | 000 |
| 04048551207772 | K944797 | 000 |
| 04048551213575 | K944797 | 000 |