The following data is part of a premarket notification filed by Enamelite Llc with the FDA for Enamelite Acryseal Spray Sealant.
Device ID | K093019 |
510k Number | K093019 |
Device Name: | ENAMELITE ACRYSEAL SPRAY SEALANT |
Classification | Coating, Filling Material, Resin |
Applicant | ENAMELITE LLC 8708 CAPEHART COVE Austin, TX 78733 |
Contact | David C Furr |
Correspondent | David C Furr ENAMELITE LLC 8708 CAPEHART COVE Austin, TX 78733 |
Product Code | EBD |
CFR Regulation Number | 872.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-29 |
Decision Date | 2009-12-22 |
Summary: | summary |