Device Classification Name |
Indicator, Biological Sterilization Process
|
510(k) Number |
K921909 |
Device Name |
STERRAD BI TEST PACK |
Applicant |
JOHNSON & JOHNSON MEDICAL, INC. |
P.O. BOX 90130 |
ARLINGTON,
TX
76004 -3130
|
|
Applicant Contact |
WENDT |
Correspondent |
JOHNSON & JOHNSON MEDICAL, INC. |
P.O. BOX 90130 |
ARLINGTON,
TX
76004 -3130
|
|
Correspondent Contact |
WENDT |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 04/23/1992 |
Decision Date | 10/01/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|