The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Painpump2.
Device ID | K030661 |
510k Number | K030661 |
Device Name: | STRYKER PAINPUMP2 |
Classification | Pump, Infusion, Pca |
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 | MEA |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-03 |
Decision Date | 2003-05-30 |
Summary: | summary |