The following data is part of a premarket notification filed by Command Medical Products with the FDA for Huberpro Safety Huber Infusion Set.
Device ID | K033515 |
510k Number | K033515 |
Device Name: | HUBERPRO SAFETY HUBER INFUSION SET |
Classification | Set, Administration, Intravascular |
Applicant | COMMAND MEDICAL PRODUCTS 15 SIGNAL AVE. Ormond Beach, FL 32174 |
Contact | Joyce Vytlacil |
Correspondent | Joyce Vytlacil COMMAND MEDICAL PRODUCTS 15 SIGNAL AVE. Ormond Beach, FL 32174 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-06 |
Decision Date | 2004-01-22 |
Summary: | summary |