The following data is part of a premarket notification filed by Ximex, Ltd. with the FDA for Plakof.
| Device ID | K890910 |
| 510k Number | K890910 |
| Device Name: | PLAKOF |
| Classification | Pick, Massaging |
| Applicant | XIMEX, LTD. 63 LOWTHER ROAD BARNES, LONDON England Sw13 9nt, GB |
| Contact | Salam |
| Correspondent | Salam XIMEX, LTD. 63 LOWTHER ROAD BARNES, LONDON England Sw13 9nt, GB |
| Product Code | JET |
| CFR Regulation Number | 872.6650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-23 |
| Decision Date | 1989-03-16 |