The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Pci W/cath-seal Side Flow Fitting.
Device ID | K842259 |
510k Number | K842259 |
Device Name: | PCI W/CATH-SEAL SIDE FLOW FITTING |
Classification | Introducer, Catheter |
Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-07 |
Decision Date | 1984-08-01 |