The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Davol Laparoscopic Insufflation Needle For General Laparoscopic Procedures.
| Device ID | K936102 |
| 510k Number | K936102 |
| Device Name: | DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Jeanette G Cloutier |
| Correspondent | Jeanette G Cloutier DAVOL, INC., SUB. C.R. BARD, 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 | 1993-12-22 |
| Decision Date | 1994-05-17 |