The following data is part of a premarket notification filed by Aurolab with the FDA for Silk Sutures.
| Device ID | K024091 |
| 510k Number | K024091 |
| Device Name: | SILK SUTURES |
| Classification | Suture, Nonabsorbable, Silk |
| 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 | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| 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 |
|---|---|---|
| 10803878029091 | K024091 | 000 |
| 10803878029084 | K024091 | 000 |
| 10803878029077 | K024091 | 000 |
| 10803878028933 | K024091 | 000 |
| 10803878028902 | K024091 | 000 |
| 00814106016151 | K024091 | 000 |