The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Matrx Medical Maximizer 1000 And 2000 Vacuum Pump.
| Device ID | K915353 |
| 510k Number | K915353 |
| Device Name: | MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP |
| Classification | Unit, Operative Dental |
| Applicant | MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Contact | David Johannes |
| Correspondent | David Johannes MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1991-12-27 |