Device Classification Name |
coagulator-cutter, endoscopic, unipolar (and accessories)
|
510(k) Number |
K971146 |
Device Name |
LAPARETTE |
Applicant |
RD CHUS, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
RD CHUS, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 884.4160
|
Classification Product Code |
|
Date Received | 03/28/1997 |
Decision Date | 08/25/1997 |
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
|
|
|