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 | K832545 |
510k Number | K832545 |
Device Name: | ARTERIAL BLOOD SAMPLING KIT |
Classification | Arterial Blood Sampling Kit |
Applicant | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CBT |
CFR Regulation Number | 868.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-29 |
Decision Date | 1983-09-26 |