The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Command 2 Micoelectric Surgical System.
Device ID | K961970 |
510k Number | K961970 |
Device Name: | COMMAND 2 MICOELECTRIC SURGICAL SYSTEM |
Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
Applicant | STRYKER CORP. 2725 FAIRFIELD RD. Kalamazoo, MI 49002 |
Contact | Diane Davis |
Correspondent | Diane Davis STRYKER CORP. 2725 FAIRFIELD RD. Kalamazoo, MI 49002 |
Product Code | HWE |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-20 |
Decision Date | 1996-07-26 |
Summary: | summary |