The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Aegis Pit & Fissure Sealant With Acp.
| Device ID | K033751 |
| 510k Number | K033751 |
| Device Name: | AEGIS PIT & FISSURE SEALANT WITH ACP |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Contact | Mildred M Goldstein |
| Correspondent | Mildred M Goldstein HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-01 |
| Decision Date | 2004-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519021524 | K033751 | 000 |
| H66809213481 | K033751 | 000 |
| H6680921328S1 | K033751 | 000 |
| H66809213281 | K033751 | 000 |
| H66809213271 | K033751 | 000 |