The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Fisch Titanium Middle Ear Prostheses.
| Device ID | K043375 |
| 510k Number | K043375 |
| Device Name: | FISCH TITANIUM MIDDLE EAR PROSTHESES |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Contact | Yvonne Fernandez |
| Correspondent | Yvonne Fernandez KARL STORZ ENDOSCOPY 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-08 |
| Decision Date | 2005-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551083208 | K043375 | 000 |
| 04048551083192 | K043375 | 000 |