The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Davol Arthro-flo 3.
| Device ID | K951026 |
| 510k Number | K951026 |
| Device Name: | DAVOL ARTHRO-FLO 3 |
| Classification | Arthroscope |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Doris Peterkin |
| Correspondent | Doris Peterkin DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-06 |
| Decision Date | 1995-06-02 |