Device Classification Name |
speculum, vaginal, nonmetal
|
510(k) Number |
K822086 |
Device Name |
DIA-SPEC |
Applicant |
EXITEC, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
EXITEC, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 07/13/1982 |
Decision Date | 11/08/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|