The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Limited Reuse Blades.
| Device ID | K943985 |
| 510k Number | K943985 |
| Device Name: | LIMITED REUSE BLADES |
| Classification | Arthroscope |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1994-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854020443 | K943985 | 000 |
| 30845854013087 | K943985 | 000 |
| 30845854020320 | K943985 | 000 |
| 30845854020337 | K943985 | 000 |
| 30845854020344 | K943985 | 000 |
| 30845854020351 | K943985 | 000 |
| 30845854020368 | K943985 | 000 |
| 30845854020382 | K943985 | 000 |
| 30845854020399 | K943985 | 000 |
| 30845854020405 | K943985 | 000 |
| 30845854020412 | K943985 | 000 |
| 30845854020429 | K943985 | 000 |
| 30845854020436 | K943985 | 000 |
| 30845854013070 | K943985 | 000 |