Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K962482 |
Device Name |
SCUBA SYSTEM |
Applicant |
GYNECARE, INC. |
235 CONSTITUTION DR. |
MENIO PARK,
CA
94025
|
|
Applicant Contact |
MILTON B MCCOLL, M.D. |
Correspondent |
GYNECARE, INC. |
235 CONSTITUTION DR. |
MENIO PARK,
CA
94025
|
|
Correspondent Contact |
MILTON B MCCOLL, M.D. |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 06/26/1996 |
Decision Date | 11/01/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|