Device Classification Name |
Apparatus, Electrosurgical
|
510(k) Number |
K913300 |
Device Name |
LAPAROSTAT(TM) |
Applicant |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Applicant Contact |
MICHELLE YOUNG |
Correspondent |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
MICHELLE YOUNG |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/25/1991 |
Decision Date | 04/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|