The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Optical Mediastinoscope.
| Device ID | K954910 |
| 510k Number | K954910 |
| Device Name: | KARL STORZ OPTICAL MEDIASTINOSCOPE |
| Classification | Mediastinoscope, Surgical |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Renate A Maclaren |
| Correspondent | Renate A Maclaren KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | EWY |
| CFR Regulation Number | 874.4720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-25 |
| Decision Date | 1995-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551322062 | K954910 | 000 |
| 04048551242889 | K954910 | 000 |
| 04048551225424 | K954910 | 000 |
| 04048551225387 | K954910 | 000 |
| 04048551049570 | K954910 | 000 |