Device Classification Name |
Sterilizer, Steam
|
510(k) Number |
K180272 |
Device Name |
Saniclave 250 |
Applicant |
REVOLUTIONARY SCIENCE |
17319 Lake Blvd |
Shafer,
MN
55074
|
|
Applicant Contact |
Isaac Erickson |
Correspondent |
REVOLUTIONARY SCIENCE |
17319 Lake Blvd |
Shafer,
MN
55074
|
|
Correspondent Contact |
Isaac Erickson |
Regulation Number | 880.6880
|
Classification Product Code |
|
Date Received | 01/31/2018 |
Decision Date | 07/26/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|