The following data is part of a premarket notification filed by Aurolab with the FDA for Nylon Suture.
| Device ID | K024090 |
| 510k Number | K024090 |
| Device Name: | NYLON SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | AUROLAB 6441 ENTERPRISE LN. SUITE 214 Madison, WI 53719 |
| Contact | Michael G Price |
| Correspondent | Michael G Price AUROLAB 6441 ENTERPRISE LN. SUITE 214 Madison, WI 53719 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-11 |
| Decision Date | 2003-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00803878030045 | K024090 | 000 |
| 00814106015956 | K024090 | 000 |
| 00814106015970 | K024090 | 000 |
| 00814106015994 | K024090 | 000 |
| 00814106016014 | K024090 | 000 |
| 00814106016038 | K024090 | 000 |
| 00814106016052 | K024090 | 000 |
| 10803878028827 | K024090 | 000 |
| 10803878028834 | K024090 | 000 |
| 10803878028858 | K024090 | 000 |
| 10803878028865 | K024090 | 000 |
| 10803878028896 | K024090 | 000 |
| 10803878067246 | K024090 | 000 |
| 00803878028875 | K024090 | 000 |
| 00803878028929 | K024090 | 000 |
| 00803878028974 | K024090 | 000 |
| 00803878029186 | K024090 | 000 |
| 00803878029193 | K024090 | 000 |
| 00803878044721 | K024090 | 000 |