Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K994418 |
Device Name |
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
GREGORY JONES |
Correspondent |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Correspondent Contact |
GREGORY JONES |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/29/1999 |
Decision Date | 01/24/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|