The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Integrated Bipolar Cord And Tubing Sets.
Device ID | K172367 |
510k Number | K172367 |
Device Name: | Stryker Integrated Bipolar Cord And Tubing Sets |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 |
Contact | Susanne Galin |
Correspondent | Susanne Galin Stryker Instruments 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 | 2017-08-04 |
Decision Date | 2017-08-22 |
Summary: | summary |