The following data is part of a premarket notification filed by Dunamis Llc with the FDA for Dunamis Force Dfx Suture, Size 5, Dunamis Force Dfx Suture Size 2.
| Device ID | K150327 |
| 510k Number | K150327 |
| Device Name: | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Dunamis LLC 693 Sherling Lake Rd. Greenville, AL 36037 |
| Contact | Prithviraj Chavan |
| Correspondent | Robert O Dean LEXAMED 705 FRONT ST. Toledo, OH 43605 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-10 |
| Decision Date | 2015-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854629006505 | K150327 | 000 |
| 10854629006489 | K150327 | 000 |
| 00850052601188 | K150327 | 000 |