Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K013228 |
Device Name |
3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR |
Applicant |
MINNESOTA MINING AND MFG. CO. |
5353 WAYZATA BLVD. |
SUITE 505 |
MINNEAPOLIS,
MN
55416
|
|
Applicant Contact |
TIERNEY NORSTED |
Correspondent |
MINNESOTA MINING AND MFG. CO. |
5353 WAYZATA BLVD. |
SUITE 505 |
MINNEAPOLIS,
MN
55416
|
|
Correspondent Contact |
TIERNEY NORSTED |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 09/27/2001 |
Decision Date | 01/18/2002 |
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
|
Recalls |
CDRH Recalls
|
|
|