The following data is part of a premarket notification filed by United Medical Industries Co. Ltd. with the FDA for Uniplain & Unichrom.
| Device ID | K042287 |
| 510k Number | K042287 |
| Device Name: | UNIPLAIN & UNICHROM |
| Classification | Suture, Absorbable, Natural |
| Applicant | UNITED MEDICAL INDUSTRIES CO. LTD. P.O. BOX 51871 Riyadh, Central Province, SA 11553 |
| Contact | Mohammed Azeez |
| Correspondent | Mohammed Azeez UNITED MEDICAL INDUSTRIES CO. LTD. P.O. BOX 51871 Riyadh, Central Province, SA 11553 |
| Product Code | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-24 |
| Decision Date | 2005-09-07 |