Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K982149 |
Device Name |
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE |
Applicant |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
DEBORAH J CONNORS |
Correspondent |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
DEBORAH J CONNORS |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 06/18/1998 |
Decision Date | 09/10/1998 |
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
|
|
|