The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Arthroscopic Irrigation Pump.
| Device ID | K863605 |
| 510k Number | K863605 |
| Device Name: | ARTHROSCOPIC IRRIGATION PUMP |
| Classification | Arthroscope |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Dieck, Phd |
| Correspondent | Dieck, Phd 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 | 1986-09-16 |
| Decision Date | 1986-10-03 |