The following data is part of a premarket notification filed by Wrapped In Comfort with the FDA for Incubator Cape.
| Device ID | K040794 |
| 510k Number | K040794 |
| Device Name: | INCUBATOR CAPE |
| Classification | Cover, Barrier, Protective |
| Applicant | WRAPPED IN COMFORT 15760 VIA SONATA San Lorenzo, CA 94580 |
| Contact | Jane Getsla |
| Correspondent | Jane Getsla WRAPPED IN COMFORT 15760 VIA SONATA San Lorenzo, CA 94580 |
| Product Code | MMP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-06-10 |