The following data is part of a premarket notification filed by Control Medical Technology with the FDA for Aspire Mechanical Aspirator G.
| Device ID | K200629 |
| 510k Number | K200629 |
| Device Name: | Aspire Mechanical Aspirator G |
| Classification | Syringe, Piston |
| Applicant | Control Medical Technology 2757 South 300 West Suite F (ZIEN) Salt Lake City, UT 84115 |
| Contact | Shawn Fojtik |
| Correspondent | Shawn Fojtik Control Medical Technology 2757 South 300 West Suite F (ZIEN) Salt Lake City, UT 84115 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-10 |
| Decision Date | 2020-05-29 |