The following data is part of a premarket notification filed by Peak Surgical, Inc. with the FDA for Peak Pulsar Ii Generator Model Ps100-102.
| Device ID | K102029 |
| 510k Number | K102029 |
| Device Name: | PEAK PULSAR II GENERATOR MODEL PS100-102 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-19 |
| Decision Date | 2010-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169467361 | K102029 | 000 |
| 00643169467354 | K102029 | 000 |
| 00643169078444 | K102029 | 000 |