The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Neptune E-sep Smoke Evacuation Pencil.
Device ID | K153679 |
510k Number | K153679 |
Device Name: | Stryker Neptune E-SEP Smoke Evacuation Pencil |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | STRYKER CORPORATION 4100 E. MILHAM AVENUE Kalamazoo, MI 49001 |
Contact | Mairead Twomey |
Correspondent | Mairead Twomey STRYKER CORPORATION 4100 E. MILHAM AVENUE Kalamazoo, MI 49001 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-12-21 |
Decision Date | 2016-01-22 |
Summary: | summary |