The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Sterile Water For Inhalation Flex Bag, Usp.
| Device ID | K090915 |
| 510k Number | K090915 |
| Device Name: | STERILE WATER FOR INHALATION FLEX BAG, USP |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD- MPKB-2B Mcgaw Park, IL 60085 |
| Contact | Kimberly Southwell |
| Correspondent | Ned Divine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190752196445 | K090915 | 000 |
| 10190752196438 | K090915 | 000 |