The following data is part of a premarket notification filed by Plastic Surgery Solutions, Llc with the FDA for Nightform.
| Device ID | K041996 |
| 510k Number | K041996 |
| Device Name: | NIGHTFORM |
| Classification | Holder, Infant Position |
| Applicant | PLASTIC SURGERY SOLUTIONS, LLC 1150 N. 35TH AVE., STE. 490 Hollywood, FL 33021 |
| Contact | Phil Carter |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | FRP |
| CFR Regulation Number | 880.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-26 |
| Decision Date | 2004-08-03 |
| Summary: | summary |