The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Arthroscopic Irrigation Sets-2c4030/31.
Device ID | K823496 |
510k Number | K823496 |
Device Name: | ARTHROSCOPIC IRRIGATION SETS-2C4030/31 |
Classification | Catheter, Irrigation |
Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GBX |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-23 |
Decision Date | 1982-12-28 |