The following data is part of a premarket notification filed by United Medical Industries Co. Ltd. with the FDA for Uniglactin.
| Device ID | K072645 |
| 510k Number | K072645 |
| Device Name: | UNIGLACTIN |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | UNITED MEDICAL INDUSTRIES CO. LTD. 3RD INDUSTRIAL CITY P.O. BOX 51871 Riyadh, Central Province, SA 11553 |
| Contact | R Raghunathan |
| Correspondent | R Raghunathan UNITED MEDICAL INDUSTRIES CO. LTD. 3RD INDUSTRIAL CITY P.O. BOX 51871 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 | 2007-09-18 |
| Decision Date | 2007-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06285379148834 | K072645 | 000 |