The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for Arterial Blood Sampling Kit.
Device ID | K821406 |
510k Number | K821406 |
Device Name: | ARTERIAL BLOOD SAMPLING KIT |
Classification | Arterial Blood Sampling Kit |
Applicant | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBT |
CFR Regulation Number | 868.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-05-11 |
Decision Date | 1982-06-25 |