The following data is part of a premarket notification filed by Precept, Inc. with the FDA for Shirt, Mitten Cuff Infant.
| Device ID | K760360 |
| 510k Number | K760360 |
| Device Name: | SHIRT, MITTEN CUFF INFANT |
| Classification | Gown, Examination |
| Applicant | PRECEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FME |
| CFR Regulation Number | 880.6265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-02 |
| Decision Date | 1976-10-20 |