The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Xenon-100 Scb Light Source, Model 20132620.
| Device ID | K082925 |
| 510k Number | K082925 |
| Device Name: | XENON-100 SCB LIGHT SOURCE, MODEL 20132620 |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE DRIVE Culver City, CA 90230 |
| Contact | Monika Campbell |
| Correspondent | Monika Campbell KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE DRIVE Culver City, CA 90230 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-01 |
| Decision Date | 2008-12-18 |
| Summary: | summary |