The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Ailee Sutures And Ailee Needles.
| Device ID | K982646 |
| 510k Number | K982646 |
| Device Name: | AILEE SUTURES AND AILEE NEEDLES |
| Classification | Suture, Absorbable, Natural |
| Applicant | MYCO MEDICAL SUPPLIES, INC. 101 ROSE VALLEY WOODS DR. Cary, NC 27513 |
| Contact | Sanjiv Kumar |
| Correspondent | Sanjiv Kumar MYCO MEDICAL SUPPLIES, INC. 101 ROSE VALLEY WOODS DR. Cary, NC 27513 |
| Product Code | GAL |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAN |
| Subsequent Product Code | GAO |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GAS |
| Subsequent Product Code | GAW |
| Subsequent Product Code | HMN |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-29 |
| Decision Date | 1999-06-02 |