Device Classification Name |
chamber, oxygen, topical, extremity
|
510(k) Number |
K882461 |
Device Name |
O2 CARE |
Applicant |
BALLARD MEDICAL PRODUCTS |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Applicant Contact |
ERNEST CHAMBERLAIN |
Correspondent |
BALLARD MEDICAL PRODUCTS |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Correspondent Contact |
ERNEST CHAMBERLAIN |
Regulation Number | 878.5650
|
Classification Product Code |
|
Date Received | 06/15/1988 |
Decision Date | 11/28/1988 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|