The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Endo-flo Suct/irri Probe (for Gen Surgery).
| Device ID | K914526 |
| 510k Number | K914526 |
| Device Name: | DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Robin M Drago |
| Correspondent | Robin M Drago DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-09 |
| Decision Date | 1991-11-22 |