The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Bosworth Seal.
| Device ID | K051224 |
| 510k Number | K051224 |
| Device Name: | BOSWORTH SEAL |
| 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 | 2005-05-12 |
| Decision Date | 2005-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66809210511 | K051224 | 000 |
| H66809210501 | K051224 | 000 |