The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmi Pk Button Electrode.
| Device ID | K093181 |
| 510k Number | K093181 |
| Device Name: | GYRUS ACMI PK BUTTON ELECTRODE |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham A.l. Baillie |
| Correspondent | Graham A.l. Baillie GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-08 |
| Decision Date | 2010-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925011519 | K093181 | 000 |