The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Suction/irrigator W/ Interchangeable Tip.
| Device ID | K921405 |
| 510k Number | K921405 |
| Device Name: | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP |
| Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Annette M Fagnant |
| Correspondent | Annette M Fagnant DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | HFG |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1994-03-25 |