The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Capsular Shrinkage Electrode.
| Device ID | K991830 |
| 510k Number | K991830 |
| Device Name: | CAPSULAR SHRINKAGE ELECTRODE |
| Classification | Electrode, Electrosurgical |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura Seneff |
| Correspondent | Laura Seneff LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-28 |
| Decision Date | 1999-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854021863 | K991830 | 000 |
| 20845854021856 | K991830 | 000 |