Device Classification Name |
Patient Examination Glove
|
510(k) Number |
K821028 |
Device Name |
FINGER COTS |
Applicant |
|
Correspondent |
|
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 04/13/1982 |
Decision Date | 04/26/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|