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 |