The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Radionics Sluijter-mehta Cannula.
| Device ID | K963577 |
| 510k Number | K963577 |
| Device Name: | RADIONICS SLUIJTER-MEHTA CANNULA |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Amy Laforte Ph.d. |
| Correspondent | Amy Laforte Ph.d. RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-06 |
| Decision Date | 1996-11-21 |
| Summary: | summary |