The following data is part of a premarket notification filed by Sherpa Korea with the FDA for Delikit Putty, Delikit Heavy Body, Delikit Light Body.
| Device ID | K103346 |
| 510k Number | K103346 |
| Device Name: | DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY |
| Classification | Material, Impression |
| Applicant | SHERPA KOREA 56B SHADOWBROOK DR Hudson, NH 03051 |
| Contact | Raymond Kelly |
| Correspondent | Raymond Kelly SHERPA KOREA 56B SHADOWBROOK DR Hudson, NH 03051 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-15 |
| Decision Date | 2011-02-11 |