The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Rigid Telescopes.
| Device ID | K943904 |
| 510k Number | K943904 |
| Device Name: | RIGID TELESCOPES |
| Classification | Telescope, Laryngeal-bronchial |
| Applicant | KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | ENZ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-11 |
| Decision Date | 1994-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551045114 | K943904 | 000 |