The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Bosworth Copalioner.
| Device ID | K933505 |
| 510k Number | K933505 |
| Device Name: | BOSWORTH COPALIONER |
| Classification | Varnish, Cavity |
| 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 | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-15 |
| Decision Date | 1994-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66809215271 | K933505 | 000 |
| H66809215261 | K933505 | 000 |
| H66809215251 | K933505 | 000 |