Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K811270 |
Device Name |
SCOPE MASTER |
Applicant |
SYNEMED, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SYNEMED, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 05/06/1981 |
Decision Date | 09/08/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|