Device Classification Name |
sterilizer, ethylene-oxide gas
|
510(k) Number |
K812867 |
Device Name |
STERI-VAC #400C GAS STERILIZER |
Applicant |
3M COMPANY |
2724 SOUTH PECK RD. |
MONROVIA,
CA
91016
|
|
Correspondent |
3M COMPANY |
2724 SOUTH PECK RD. |
MONROVIA,
CA
91016
|
|
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 10/13/1981 |
Decision Date | 11/02/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|