The following data is part of a premarket notification filed by Microsulis Medical Limited with the FDA for Acculis Accu2i Pmta Applicator Model Accu2i.
| Device ID | K094021 |
| 510k Number | K094021 |
| Device Name: | ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | MICROSULIS MEDICAL LIMITED UNITS 1 & 2 FALCON COURT PARKLANDS BUSINESS PARK Denmead Hampshire, GB Po7 6xp |
| Contact | Denise Rexhaus |
| Correspondent | Denise Rexhaus MICROSULIS MEDICAL LIMITED UNITS 1 & 2 FALCON COURT PARKLANDS BUSINESS PARK Denmead Hampshire, GB Po7 6xp |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-30 |
| Decision Date | 2010-08-06 |
| Summary: | summary |