Device Classification Name |
syringe, piston
|
510(k) Number |
K200629 |
Device Name |
Aspire Mechanical Aspirator G |
Applicant |
Control Medical Technology |
2757 South 300 West Suite F (ZIEN) |
Salt Lake City,
UT
84115
|
|
Applicant Contact |
Shawn Fojtik |
Correspondent |
Control Medical Technology |
2757 South 300 West Suite F (ZIEN) |
Salt Lake City,
UT
84115
|
|
Correspondent Contact |
Shawn Fojtik |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 03/10/2020 |
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
|
|
|