The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker L3 Hydrolert.
Device ID | K022248 |
510k Number | K022248 |
Device Name: | STRYKER L3 HYDROLERT |
Classification | Monitor, Electric For Gravity Flow Infusion Systems |
Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Contact | Michael Hilldoerfer |
Correspondent | Michael Hilldoerfer Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Product Code | FLN |
CFR Regulation Number | 880.2420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-12 |
Decision Date | 2002-08-06 |
Summary: | summary |