The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Therapeutic Exchange Blood Tubing-tp-101.
Device ID | K831424 |
510k Number | K831424 |
Device Name: | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 |
Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FJK |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-03 |
Decision Date | 1983-10-14 |