The following data is part of a premarket notification filed by United Medical Industries Co. Ltd. with the FDA for Uniester C.
| Device ID | K042286 |
| 510k Number | K042286 |
| Device Name: | UNIESTER C |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | UNITED MEDICAL INDUSTRIES CO. LTD. 3RD INDUSTRIAL CITY SANAYYA, OPPOSITE TO OBAIKAN Riyadh, Central Province, SA 11553 |
| Contact | Mohammed Azeez |
| Correspondent | Mohammed Azeez UNITED MEDICAL INDUSTRIES CO. LTD. 3RD INDUSTRIAL CITY SANAYYA, OPPOSITE TO OBAIKAN Riyadh, Central Province, SA 11553 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-24 |
| Decision Date | 2004-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06285379148933 | K042286 | 000 |
| 06285379148926 | K042286 | 000 |