The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Epic D215.
Device ID | K790574 |
510k Number | K790574 |
Device Name: | EPIC D215 |
Classification | Set, Administration, Intravascular |
Applicant | NATIONAL PATENT DEVELOPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-23 |
Decision Date | 1979-04-30 |