The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol X-stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005.
| Device ID | K003790 |
| 510k Number | K003790 |
| Device Name: | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DAVOL, INC. SUBSIDIARY OF C.R. BARD 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Lucinda L Fox |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2000-12-22 |