510(k) K200629

Aspire Mechanical Aspirator G by Control Medical Technology — Product Code FMF

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