The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Arthroscopic Infusion Pump.
Device ID | K910858 |
510k Number | K910858 |
Device Name: | STRYKER ARTHROSCOPIC INFUSION PUMP |
Classification | Arthroscope |
Applicant | STRYKER CORP. 781 LENOX AVE. Portage, MI 49002 |
Contact | Harmon Woodworth |
Correspondent | Harmon Woodworth STRYKER CORP. 781 LENOX AVE. Portage, MI 49002 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-28 |
Decision Date | 1991-05-23 |