The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Alginate Impression Material Ii (fast & Regular Set).
| Device ID | K991490 |
| 510k Number | K991490 |
| Device Name: | ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-28 |
| Decision Date | 1999-07-15 |