The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Respir Ther Humid Contain Sterile Water For Usp.
Device ID | K853146 |
510k Number | K853146 |
Device Name: | RESPIR THER HUMID CONTAIN STERILE WATER FOR USP |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
Applicant | AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock, IL 60098 |
Contact | Frank Leo |
Correspondent | Frank Leo AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock, IL 60098 |
Product Code | BTT |
CFR Regulation Number | 868.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-29 |
Decision Date | 1985-08-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10190752141643 | K853146 | 000 |