The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Adhesion Promotor.
Device ID | K760419 |
510k Number | K760419 |
Device Name: | ADHESION PROMOTOR |
Classification | Coating, Filling Material, Resin |
Applicant | LEE PHARMACEUTICALS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EBD |
CFR Regulation Number | 872.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-09 |
Decision Date | 1976-08-23 |