The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Mvs 19 & 20 Gauge Scleral Plugs.
| Device ID | K854507 |
| 510k Number | K854507 |
| Device Name: | STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS |
| Classification | Plug, Scleral |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Dan Regan |
| Correspondent | Dan Regan STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | LXP |
| CFR Regulation Number | 886.4155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1986-02-07 |