The following data is part of a premarket notification filed by Bosworth Co. with the FDA for Lc Pit & Fissure Sealant.
| Device ID | K991902 |
| 510k Number | K991902 |
| Device Name: | LC PIT & FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 -3999 |
| Contact | Mildred M Goldstein |
| Correspondent | Mildred M Goldstein BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 -3999 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-04 |
| Decision Date | 1999-07-26 |