| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K893749 |
| Device Name |
CN GLOVES |
| Applicant |
| C.N. Technocrats |
| 62a/3 Manickam Mansions |
| Thayar Sahib St. Mount Rd. |
|
Madras-600 002 India,
IN
|
|
| Applicant Contact |
BANERJI |
| Correspondent |
| C.N. Technocrats |
| 62a/3 Manickam Mansions |
| Thayar Sahib St. Mount Rd. |
|
Madras-600 002 India,
IN
|
|
| Correspondent Contact |
BANERJI |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 05/18/1989 |
| Decision Date | 09/26/1989 |
| 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
|
|
|