The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Poly Blades.
| Device ID | K940515 |
| 510k Number | K940515 |
| Device Name: | POLY BLADES |
| Classification | Arthroscope |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Contact | Carol A Weideman, Ph.d. |
| Correspondent | Carol A Weideman, Ph.d. 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 | 1994-02-04 |
| Decision Date | 1994-05-26 |