The following data is part of a premarket notification filed by Convertors with the FDA for Pediatrics Gown.
| Device ID | K771929 |
| 510k Number | K771929 |
| Device Name: | PEDIATRICS GOWN |
| Classification | Gown, Patient |
| Applicant | CONVERTORS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYB |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-14 |
| Decision Date | 1977-11-16 |