The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Silicone Soft Reline.
| Device ID | K981691 |
| 510k Number | K981691 |
| Device Name: | SILICONE SOFT RELINE |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-13 |
| Decision Date | 1998-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66809212781 | K981691 | 000 |
| H66809212761 | K981691 | 000 |
| H66809212751 | K981691 | 000 |