Device Classification Name |
brush, scrub, operating-room
|
510(k) Number |
K843636 |
Device Name |
FOAM CARE ONE STEP PREP |
Applicant |
BALLARD MEDICAL PRODUCTS |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Applicant Contact |
ERNEST M CHAMBERLAI |
Correspondent |
BALLARD MEDICAL PRODUCTS |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Correspondent Contact |
ERNEST M CHAMBERLAI |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 09/17/1984 |
Decision Date | 11/16/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|