510(k) K200629
K200629 is an FDA 510(k) premarket notification submitted by Control Medical Technology for the device "Aspire Mechanical Aspirator G". The FDA issued a decision of Substantially Equivalent on May 29, 2020. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Control Medical Technology has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2020
- Date Received
- March 10, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type