The following data is part of a premarket notification filed by United Medical Industries Co. Ltd. with the FDA for Unicryl.
| Device ID | K042288 |
| 510k Number | K042288 |
| Device Name: | UNICRYL |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| 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 | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-24 |
| Decision Date | 2004-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06285379148810 | K042288 | 000 |