The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol 100cc Silicone Closed Wound Drainage Evac.
| Device ID | K915536 |
| 510k Number | K915536 |
| Device Name: | DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| 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 | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-10 |
| Decision Date | 1992-03-26 |