The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Arthrovent Outflow Tubing.
| Device ID | K030307 |
| 510k Number | K030307 |
| Device Name: | DAVOL ARTHROVENT OUTFLOW TUBING |
| Classification | Arthroscope |
| Applicant | DAVOL, INC. SUBSIDIARY OF C.R. BARD 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Lucinda L Fox |
| Correspondent | Michelle Weidman N.V. KEMA P.O. BOX 9035 6800 ET ARNHEM Arnhem, NL |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-01-29 |
| Decision Date | 2003-02-13 |
| Summary: | summary |