The following data is part of a premarket notification filed by Life Innovations Llc with the FDA for Infant Sleep Beanie.
| Device ID | K082367 |
| 510k Number | K082367 |
| Device Name: | INFANT SLEEP BEANIE |
| Classification | Holder, Infant Position |
| Applicant | LIFE INNOVATIONS LLC P.O. BOX 148 Wellington, CO 80549 |
| Contact | Jane Scott |
| Correspondent | Jane Scott LIFE INNOVATIONS LLC P.O. BOX 148 Wellington, CO 80549 |
| Product Code | FRP |
| CFR Regulation Number | 880.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-18 |
| Decision Date | 2009-06-12 |
| Summary: | summary |