The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Xenon Light Source.
| Device ID | K984124 |
| 510k Number | K984124 |
| Device Name: | AESCULAP XENON LIGHT SOURCE |
| Classification | Light, Surgical, Floor Standing |
| Applicant | AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Contact | Mary Ellen Holden |
| Correspondent | Mary Ellen Holden AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-18 |
| Decision Date | 1999-02-01 |
| Summary: | summary |