The following data is part of a premarket notification filed by Henry Schein, Inc. with the FDA for Schein Ap-1 Air Polishing Unit.
| Device ID | K862384 |
| 510k Number | K862384 |
| Device Name: | SCHEIN AP-1 AIR POLISHING UNIT |
| Classification | Airbrush |
| Applicant | HENRY SCHEIN, INC. 5 HARBOR PARK DR. Port Washington, NY 11050 |
| Contact | Michael J Mahr |
| Correspondent | Michael J Mahr HENRY SCHEIN, INC. 5 HARBOR PARK DR. Port Washington, NY 11050 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-24 |
| Decision Date | 1986-11-07 |