The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Teflon Coated Guide Wires & Catheter.
Device ID | K822586 |
510k Number | K822586 |
Device Name: | TEFLON COATED GUIDE WIRES & CATHETER |
Classification | Wire, Guide, Catheter |
Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-26 |
Decision Date | 1982-10-18 |