The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Xenon Light Source For Endoscopic Procedures.
| Device ID | K863986 |
| 510k Number | K863986 |
| Device Name: | XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES |
| Classification | Arthroscope |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Ronald L Dieck |
| Correspondent | Ronald L Dieck AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1986-10-31 |