The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmil Bipolarlaproscopic Loop (pks Bill).
Device ID | K111059 |
510k Number | K111059 |
Device Name: | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) |
Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
Contact | Lorraine Calzetta |
Correspondent | Lorraine Calzetta GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
Product Code | HIN |
CFR Regulation Number | 884.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-18 |
Decision Date | 2011-09-01 |
Summary: | summary |