The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Mvs 19 And Mvs 20 Gauge Scleral Plugs.
| Device ID | K871604 |
| 510k Number | K871604 |
| Device Name: | MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS |
| Classification | Plug, Scleral |
| Applicant | ADVANCED SURGICAL PRODUCTS, INC. 524 CHELE DRIVE ST. Charles, MO 63303 |
| Contact | Todd Hessel |
| Correspondent | Todd Hessel ADVANCED SURGICAL PRODUCTS, INC. 524 CHELE DRIVE ST. Charles, MO 63303 |
| Product Code | LXP |
| CFR Regulation Number | 886.4155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-24 |
| Decision Date | 1987-06-12 |