The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Telescope Bridges And Adapters.
| Device ID | K945527 |
| 510k Number | K945527 |
| Device Name: | KARL STORZ TELESCOPE BRIDGES AND ADAPTERS |
| Classification | Cystoscope And Accessories, Flexible/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 | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-10 |
| Decision Date | 1994-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551095089 | K945527 | 000 |
| 04048551320792 | K945527 | 000 |
| 04048551233177 | K945527 | 000 |
| 04048551232965 | K945527 | 000 |
| 04048551232842 | K945527 | 000 |
| 04048551232446 | K945527 | 000 |
| 04048551232330 | K945527 | 000 |
| 04048551232026 | K945527 | 000 |
| 04048551231968 | K945527 | 000 |
| 04048551231531 | K945527 | 000 |
| 04048551231524 | K945527 | 000 |
| 04048551081761 | K945527 | 000 |
| 04048551081822 | K945527 | 000 |
| 04048551081907 | K945527 | 000 |
| 04048551093221 | K945527 | 000 |
| 04048551091630 | K945527 | 000 |
| 04048551083536 | K945527 | 000 |
| 04048551083512 | K945527 | 000 |
| 04048551077887 | K945527 | 000 |
| 04048551077290 | K945527 | 000 |
| 04048551074749 | K945527 | 000 |
| 04048551074060 | K945527 | 000 |
| 04048551074046 | K945527 | 000 |
| 04048551082737 | K945527 | 000 |
| 04048551231517 | K945527 | 000 |