The following data is part of a premarket notification filed by Dunamis Llc with the FDA for Dunamis Force Dfx Tensile Tape.
| Device ID | K153746 |
| 510k Number | K153746 |
| Device Name: | Dunamis Force DFX Tensile Tape |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Dunamis LLC 693 Sherling Lake Rd. Apt. 122 Greenville, AL 36037 |
| Contact | Prithvi Raj Chavan |
| Correspondent | Robert O Dean Compliance Systems International, LLC 1083 Delaware Ave. Buffalo, NY 14209 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-29 |
| Decision Date | 2016-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854629006673 | K153746 | 000 |
| 00854629006369 | K153746 | 000 |
| 10854629006373 | K153746 | 000 |
| 10854629006380 | K153746 | 000 |
| 00854629006406 | K153746 | 000 |
| 00854629006420 | K153746 | 000 |
| 10854629006434 | K153746 | 000 |
| 00854629006451 | K153746 | 000 |
| 00854629006475 | K153746 | 000 |
| 10854629006540 | K153746 | 000 |
| 10854629006656 | K153746 | 000 |
| 10854629006830 | K153746 | 000 |