Device Classification Name |
sterilizer, steam
|
510(k) Number |
K220736 |
Device Name |
Consolidated HC Steam Sterilizer |
Applicant |
Consolidated Machine Corp. |
3 Enterprise Rd, Suite C |
Billerica,
MA
01821
|
|
Applicant Contact |
Arthur Trapotsis |
Correspondent |
Consolidated Machine Corp. |
3 Enterprise Rd, Suite C |
Billerica,
MA
01821
|
|
Correspondent Contact |
Arthur Trapotsis |
Regulation Number | 880.6880
|
Classification Product Code |
|
Date Received | 03/14/2022 |
Decision Date | 08/01/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|