The following data is part of a premarket notification filed by Secol Co. with the FDA for Zinc Paste Bandage.
Device ID | K802791 |
510k Number | K802791 |
Device Name: | ZINC PASTE BANDAGE |
Classification | Dressing, Wound, Drug |
Applicant | SECOL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-04 |
Decision Date | 1980-12-17 |