The following data is part of a premarket notification filed by Gyrus Acmi Inc. with the FDA for Pk Spatula.
| Device ID | K142289 |
| 510k Number | K142289 |
| Device Name: | PK Spatula |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Gyrus ACMI Inc. 136 Turnpike Road Southborough, MA 01772 |
| Contact | Neil Kelly |
| Correspondent | Neil Kelly Gyrus ACMI Inc. 136 Turnpike Road 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 | 2014-08-18 |
| Decision Date | 2014-12-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925028111 | K142289 | 000 |