The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Sterile Water For Inhalation Usp 2d0799.
Device ID | K851940 |
510k Number | K851940 |
Device Name: | STERILE WATER FOR INHALATION USP 2D0799 |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Dennis A Ocwieja |
Correspondent | Dennis A Ocwieja TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | BTT |
CFR Regulation Number | 868.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-03 |
Decision Date | 1985-06-20 |