The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Auto-d Automatic Disinfection Access/attachments.
Device ID | K850756 |
510k Number | K850756 |
Device Name: | AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS |
Classification | Subsystem, Proportioning |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Julia Meyer |
Correspondent | Julia Meyer TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | FKR |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-25 |
Decision Date | 1985-03-20 |