The following data is part of a premarket notification filed by Medical Product Specialists with the FDA for Mps Fixed Flow Rate Set.
Device ID | K982587 |
510k Number | K982587 |
Device Name: | MPS FIXED FLOW RATE SET |
Classification | Set, Administration, Intravascular |
Applicant | MEDICAL PRODUCT SPECIALISTS 499 NIBUS ST., SUITE E Brea, CA 92821 |
Contact | Dan Hyun |
Correspondent | Dan Hyun MEDICAL PRODUCT SPECIALISTS 499 NIBUS ST., SUITE E Brea, CA 92821 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-24 |
Decision Date | 1998-08-24 |
Summary: | summary |