| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K896363 |
| Device Name |
NON-STERILE LATEX EXAMINATION GLOVES |
| Applicant |
| Contemporary Medical Technology, Inc. |
| 8150 Royal Palm Blvd. #104 |
|
Coral Springs,
FL
33065
|
|
| Applicant Contact |
PAIROT TAYAPONGSAK |
| Correspondent |
| Contemporary Medical Technology, Inc. |
| 8150 Royal Palm Blvd. #104 |
|
Coral Springs,
FL
33065
|
|
| Correspondent Contact |
PAIROT TAYAPONGSAK |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 11/06/1989 |
| Decision Date | 02/13/1990 |
| 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
|
|
|