The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Enteral Nutrition Warmer.
| Device ID | K122449 |
| 510k Number | K122449 |
| Device Name: | ENTERAL NUTRITION WARMER |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | ACACIA, INC. 785 CHALLENGER ST. Brea, CA 92821 |
| Contact | Fergie Ferguson |
| Correspondent | Fergie Ferguson ACACIA, INC. 785 CHALLENGER ST. Brea, CA 92821 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-13 |
| Decision Date | 2013-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020451101696 | K122449 | 000 |
| 10020451101689 | K122449 | 000 |
| 10020451100996 | K122449 | 000 |
| 10020451100989 | K122449 | 000 |