The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Davol Delivery System.
| Device ID | K041641 |
| 510k Number | K041641 |
| Device Name: | DAVOL DELIVERY SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Suzanne Lascalza |
| 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 | 2004-06-17 |
| Decision Date | 2004-07-01 |
| Summary: | summary |