The following data is part of a premarket notification filed by Kendall Research Center with the FDA for Micronet Light Dressing Sponge.
Device ID | K780408 |
510k Number | K780408 |
Device Name: | MICRONET LIGHT DRESSING SPONGE |
Classification | Gauze / Sponge,nonresorbable For External Use |
Applicant | KENDALL RESEARCH CENTER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | NAB |
CFR Regulation Number | 878.4014 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-13 |
Decision Date | 1978-03-22 |