| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K924233 |
| Device Name |
SAVACARE LATEX EXAMINATION GLOVES |
| Applicant |
| Preventive Care, Inc. |
| 2915 Waters Rd. #100 |
|
Eagan,
MN
55121
|
|
| Applicant Contact |
ANIL SEGAT |
| Correspondent |
| Preventive Care, Inc. |
| 2915 Waters Rd. #100 |
|
Eagan,
MN
55121
|
|
| Correspondent Contact |
ANIL SEGAT |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 08/24/1992 |
| Decision Date | 03/12/1993 |
| 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
|
|
|