The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Alumina-zinc Oxide Powders F And R.
| Device ID | K983752 |
| 510k Number | K983752 |
| Device Name: | ALUMINA-ZINC OXIDE POWDERS F AND R |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-23 |
| Decision Date | 1998-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66809210141 | K983752 | 000 |
| H66809210131 | K983752 | 000 |
| H66809210121 | K983752 | 000 |
| H66809210101 | K983752 | 000 |
| H66809210091 | K983752 | 000 |
| H66809210081 | K983752 | 000 |
| H6680921007R1 | K983752 | 000 |
| H6680921007F1 | K983752 | 000 |
| H66809210071 | K983752 | 000 |