The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Hydron Wound Dressing Kit.
Device ID | K811446 |
510k Number | K811446 |
Device Name: | HYDRON WOUND DRESSING KIT |
Classification | Bandage, Liquid |
Applicant | NATIONAL PATENT DEVELOPMENT CORP. 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 | 1981-05-22 |
Decision Date | 1981-06-12 |