The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Modification To Stryker Painpump2.
Device ID | K030885 |
510k Number | K030885 |
Device Name: | MODIFICATION TO STRYKER PAINPUMP2 |
Classification | Pump, Infusion |
Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Contact | Nicole Petty |
Correspondent | Nicole Petty STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-21 |
Decision Date | 2003-04-18 |
Summary: | summary |