The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Continuous Flush Device.
Device ID | K831730 |
510k Number | K831730 |
Device Name: | CONTINUOUS FLUSH DEVICE |
Classification | Catheter, Continuous Flush |
Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-31 |
Decision Date | 1983-07-18 |