Device Classification Name |
Sterilizer, Dry Heat
|
510(k) Number |
K771070 |
Device Name |
DRY HEAT STERILIZER |
Applicant |
CPAC, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
CPAC, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 880.6870 |
Classification Product Code |
|
Date Received | 06/14/1977 |
Decision Date | 07/14/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|