The following data is part of a premarket notification filed by Kericure Inc. with the FDA for Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage.
Device ID | K131384 |
510k Number | K131384 |
Device Name: | KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE |
Classification | Bandage, Liquid |
Applicant | KERICURE INC. 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
Contact | Jonathan Ward |
Correspondent | Jonathan Ward KERICURE INC. 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-14 |
Decision Date | 2014-08-07 |
Summary: | summary |