The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Xenon 300 Light Source For Non-flash Applications.
| Device ID | K962595 |
| 510k Number | K962595 |
| Device Name: | KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-02 |
| Decision Date | 1996-09-04 |
| Summary: | summary |