The following data is part of a premarket notification filed by Freckles Publications, Inc. with the FDA for Bloom Transparent Stencil.
| Device ID | K914759 |
| 510k Number | K914759 |
| Device Name: | BLOOM TRANSPARENT STENCIL |
| Classification | Marker, Skin |
| Applicant | FRECKLES PUBLICATIONS, INC. C/O COFFEE - NOVAK, ATTORNEYS POST OFFICE BOX 3726 Lubbock, TX 79452 |
| Contact | Neal Burt |
| Correspondent | Neal Burt FRECKLES PUBLICATIONS, INC. C/O COFFEE - NOVAK, ATTORNEYS POST OFFICE BOX 3726 Lubbock, TX 79452 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-22 |
| Decision Date | 1992-04-21 |