Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K895557 |
Device Name |
PATIENT EXAMINATION GLOVES |
Applicant |
MOELLER CHEMICALS, INC. |
50 CHESTNUT RIDGE ROAD, SUITE |
102 |
MONTVALE,
NJ
07645
|
|
Applicant Contact |
GREGORY J RUMMO |
Correspondent |
MOELLER CHEMICALS, INC. |
50 CHESTNUT RIDGE ROAD, SUITE |
102 |
MONTVALE,
NJ
07645
|
|
Correspondent Contact |
GREGORY J RUMMO |
Regulation Number | 880.6250 |
Classification Product Code |
|
Date Received | 08/23/1989 |
Decision Date | 11/17/1989 |
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
|
|
|