The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Tray, Blood Sampling (pulsator Ii).
Device ID | K760086 |
510k Number | K760086 |
Device Name: | TRAY, BLOOD SAMPLING (PULSATOR II) |
Classification | Tray, Blood Collection |
Applicant | CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GJE |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-21 |
Decision Date | 1976-07-16 |