The following data is part of a premarket notification filed by Electro Medical Systems, Inc. with the FDA for Airflow Handy.
| Device ID | K991857 |
| 510k Number | K991857 |
| Device Name: | AIRFLOW HANDY |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | ELECTRO MEDICAL SYSTEMS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte ELECTRO MEDICAL SYSTEMS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 1999-10-07 |
| Summary: | summary |