The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Vigilon Primary Wound Dressing, Sterile.
Device ID | K820134 |
510k Number | K820134 |
Device Name: | VIGILON PRIMARY WOUND DRESSING, STERILE |
Classification | Bandage, Liquid |
Applicant | C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-18 |
Decision Date | 1982-02-05 |