The following data is part of a premarket notification filed by U.s. Mfg. & Management, Inc. with the FDA for Veni-shield.
Device ID | K842999 |
510k Number | K842999 |
Device Name: | VENI-SHIELD |
Classification | Device, Intravascular Catheter Securement |
Applicant | U.S. MFG. & MANAGEMENT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KMK |
CFR Regulation Number | 880.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-30 |
Decision Date | 1984-09-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VENI-SHIELD 73491611 1367472 Dead/Cancelled |
AMERICAN MEDICAL DEVICES, INC. 1984-07-25 |