Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K891498 |
Device Name |
PATIENT EXAMINATION GLOVES (LATEX) |
Applicant |
CARNEAL ENTERPRISES, INC. DIV. OAKFIELD MENS STORE |
OAKFIELD RD. |
P.O. BOX 1641 |
JACKSON,
TN
38302
|
|
Applicant Contact |
M CARNEAL |
Correspondent |
CARNEAL ENTERPRISES, INC. DIV. OAKFIELD MENS STORE |
OAKFIELD RD. |
P.O. BOX 1641 |
JACKSON,
TN
38302
|
|
Correspondent Contact |
M CARNEAL |
Regulation Number | 880.6250 |
Classification Product Code |
|
Date Received | 03/16/1989 |
Decision Date | 04/28/1989 |
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
|
|
|