The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Intelijet Tm Fluid Management System.
Device ID | K912453 |
510k Number | K912453 |
Device Name: | INTELIJET TM FLUID MANAGEMENT SYSTEM |
Classification | Arthroscope |
Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
Contact | Eric Bannon |
Correspondent | Eric Bannon SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-03 |
Decision Date | 1991-08-26 |