The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Vital Catheter.
Device ID | K791489 |
510k Number | K791489 |
Device Name: | VITAL CATHETER |
Classification | Needle, Fistula |
Applicant | HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FIE |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-03 |
Decision Date | 1979-10-26 |