The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Laparoscopic Insufflation Tubing Set.
| Device ID | K935503 |
| 510k Number | K935503 |
| Device Name: | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET |
| Classification | Insufflator, Laparoscopic |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Jeannette G Cloutier |
| Correspondent | Jeannette G Cloutier DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-16 |
| Decision Date | 1994-03-07 |