The following data is part of a premarket notification filed by Children's Mercy Hospital with the FDA for 2d Mercy Tape & 3d Mercy Tape.
| Device ID | K142469 |
| 510k Number | K142469 |
| Device Name: | 2D Mercy TAPE & 3D Mercy TAPE |
| Classification | Mercy Tape 2d And 3d Models |
| Applicant | Children's Mercy Hospital 2401 Gilham Road, Suite 0411 Kansas City, MO 64108 |
| Contact | Susan Abdel-rahman |
| Correspondent | Jan S Peterson The EMMES Corporation 401 N Washington St, Ste 700 Rockville, MD 20850 -1785 |
| Product Code | PIR |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-03 |
| Decision Date | 2015-05-01 |
| Summary: | summary |