The following data is part of a premarket notification filed by Myco Medical with the FDA for Reli Redidiox Dyed, Reli Redidiox, Reli Redidiox Undyed.
| Device ID | K161737 |
| 510k Number | K161737 |
| Device Name: | RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | MYCO MEDICAL 158 TOWERVIEW COURT Cary, NC 27513 |
| Contact | Sanjiv Kumar |
| Correspondent | E. J. Smith Smith Assoicates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-23 |
| Decision Date | 2017-03-02 |