The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Hydro-surg Laparoscopic Irrigaton Models 0026000. 0026010.
| Device ID | K961492 |
| 510k Number | K961492 |
| Device Name: | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Jeanette G Cloutier |
| Correspondent | Jeanette G Cloutier DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD 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 | 1996-04-18 |
| Decision Date | 1996-05-15 |
| Summary: | summary |