The following data is part of a premarket notification filed by Nfant Labs, Llc with the FDA for Nfant Feeding Solution.
| Device ID | K143507 |
| 510k Number | K143507 |
| Device Name: | NFANT Feeding Solution |
| Classification | Device, Biofeedback |
| Applicant | NFANT Labs, LLC 817 West Peachtree St Suite 320 Atlanta, GA 30308 |
| Contact | Lou Malice |
| Correspondent | Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, GA 30004 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-10 |
| Decision Date | 2015-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861410000246 | K143507 | 000 |
| 00861410000239 | K143507 | 000 |
| 00861410000215 | K143507 | 000 |
| 00861410000208 | K143507 | 000 |
| 00196852268917 | K143507 | 000 |