The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Command2 Office Console.
Device ID | K953071 |
510k Number | K953071 |
Device Name: | STRYKER COMMAND2 OFFICE CONSOLE |
Classification | Table, Surgical With Orthopedic Accessories, Ac-powered |
Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Contact | Tammy Lounds |
Correspondent | Tammy Lounds STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Product Code | JEA |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-30 |
Decision Date | 1995-08-08 |