The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Arthroscopy Instrument Cannula.
| Device ID | K911205 |
| 510k Number | K911205 |
| Device Name: | ARTHROSCOPY INSTRUMENT CANNULA |
| Classification | Arthroscope |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Leo Basta |
| Correspondent | Leo Basta DAVOL, 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 | 1991-03-19 |
| Decision Date | 1991-06-17 |