The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Bosworth Air Polisher.
| Device ID | K100731 |
| 510k Number | K100731 |
| Device Name: | BOSWORTH AIR POLISHER |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Contact | Gary Chuven |
| Correspondent | Gary Chuven HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-15 |
| Decision Date | 2010-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66816677C1 | K100731 | 000 |
| H66816670R1 | K100731 | 000 |
| H66816670N1 | K100731 | 000 |
| H66816670LB1 | K100731 | 000 |
| H66816670B1 | K100731 | 000 |