Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K914923 |
Device Name |
UNISURGE DISPOSABLE TROCAR |
Applicant |
UNISURGE, INC. |
1963 ROCK ST. |
SUITE 17 |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
CHARLES L ROSE |
Correspondent |
UNISURGE, INC. |
1963 ROCK ST. |
SUITE 17 |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
CHARLES L ROSE |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 11/04/1991 |
Decision Date | 09/21/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|