The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Pks Bill.
| Device ID | K122605 |
| 510k Number | K122605 |
| Device Name: | PKS BILL |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Neil Kelly |
| Correspondent | Neil Kelly GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-27 |
| Decision Date | 2012-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925027565 | K122605 | 000 |