The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Bosworth Ch I.
| Device ID | K961198 |
| 510k Number | K961198 |
| Device Name: | BOSWORTH CH I |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-27 |
| Decision Date | 1996-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519021555 | K961198 | 000 |