The following data is part of a premarket notification filed by Synergetics, Inc with the FDA for Stryker Rf Multi-lesion Generator, Model 0406-900-000.
Device ID | K071482 |
510k Number | K071482 |
Device Name: | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 |
Classification | Generator, Lesion, Radiofrequency |
Applicant | SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon, MO 63368 |
Contact | Dan Regan |
Correspondent | Dan Regan SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon, MO 63368 |
Product Code | GXD |
CFR Regulation Number | 882.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-30 |
Decision Date | 2007-12-20 |
Summary: | summary |