Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Syringe, Piston
510(k) Number K200629
Device Name Aspire Mechanical Aspirator G
Applicant
Control Medical Technology
2757 S. 300 W. Suite F (Zien)
Salt Lake City,  UT  84115
Applicant Contact Shawn Fojtik
Correspondent
Control Medical Technology
2757 S. 300 W. Suite F (Zien)
Salt Lake City,  UT  84115
Correspondent Contact Shawn Fojtik
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/10/2020
Decision Date 05/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-