The following data is part of a premarket notification filed by Medical Technologies Of Georgia with the FDA for Mli Set.
Device ID | K952392 |
510k Number | K952392 |
Device Name: | MLI SET |
Classification | Set, Administration, Intravascular |
Applicant | MEDICAL TECHNOLOGIES OF GEORGIA 5335-A DIVIDEND DR. Decatur, GA 30035 |
Contact | Deanna Gettler |
Correspondent | Deanna Gettler MEDICAL TECHNOLOGIES OF GEORGIA 5335-A DIVIDEND DR. Decatur, GA 30035 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-22 |
Decision Date | 1995-08-07 |