The following data is part of a premarket notification filed by Peak Surgical, Inc. with the FDA for Peak Plasmablade Tna Tonsil And Adenoid Tissue Dissection Device.
| Device ID | K083415 |
| 510k Number | K083415 |
| Device Name: | PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PEAK SURGICAL, INC. 2464 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | Lois Nakayama |
| Correspondent | Lois Nakayama 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 | 2008-11-18 |
| Decision Date | 2009-06-05 |
| Summary: | summary |