The following data is part of a premarket notification filed by Peak Surgical, Inc. with the FDA for Pulsar Generator, Peak Plasmablade; 4.0, Needle, And Ext Tissue Dissection Devices.
| Device ID | K082786 |
| 510k Number | K082786 |
| Device Name: | PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PEAK SURGICAL, INC. 2464 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | Grace Carlson |
| Correspondent | Grace Carlson PEAK SURGICAL, INC. 2464 EMBARCADERO WAY Palo Alto, CA 94303 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2008-12-03 |
| Summary: | summary |