The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Pks Plasma Morcellator, Models 962000pk, 3620pk.
| Device ID | K080093 |
| 510k Number | K080093 |
| Device Name: | PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Terrence E Sullivan |
| Correspondent | Terrence E Sullivan GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925010710 | K080093 | 000 |