The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc with the FDA for Telepack X Led.
| Device ID | K182696 |
| 510k Number | K182696 |
| Device Name: | Telepack X LED |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | KARL STORZ Endoscopy-America, Inc 2151 E. Grand Ave Ei Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong KARL STORZ Endoscopy-America, Inc 2151 E. Grand Ave Ei Segundo, CA 90245 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2018-11-20 |
| Summary: | summary |