The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Insta-bond.
Device ID | K810517 |
510k Number | K810517 |
Device Name: | INSTA-BOND |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-25 |
Decision Date | 1981-03-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INSTA-BOND 77655530 3663345 Live/Registered |
HCC INSURANCE HOLDINGS, INC. 2009-01-23 |