The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Suction Ora-swab(r) Brush Kit.
| Device ID | K901806 |
| 510k Number | K901806 |
| Device Name: | SUCTION ORA-SWAB(R) BRUSH KIT |
| Classification | Unit, Operative Dental |
| Applicant | SAGE PRODUCTS, INC. 680 INDUSTRIAL DR. Cary, IL 60013 |
| Contact | Paul Hanifl |
| Correspondent | Paul Hanifl SAGE PRODUCTS, INC. 680 INDUSTRIAL DR. Cary, IL 60013 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-20 |
| Decision Date | 1990-08-15 |