The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Arthroscopy Cannula.
Device ID | K894990 |
510k Number | K894990 |
Device Name: | DAVOL ARTHROSCOPY CANNULA |
Classification | Arthroscope |
Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
Contact | Annette M Fagnant |
Correspondent | Annette M Fagnant 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 | 1989-08-08 |
Decision Date | 1989-11-08 |