The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Xenon Light Source Model 201320-20.
| Device ID | K934559 |
| 510k Number | K934559 |
| Device Name: | KARL STORZ XENON LIGHT SOURCE MODEL 201320-20 |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-16 |
| Decision Date | 1994-04-22 |