Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K962702 |
Device Name |
SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA |
Applicant |
GENERAL SURGICAL INNOVATIONS |
3172-A PORTER DR. |
PALO ALTO,
CA
94304
|
|
Applicant Contact |
CATHLEEN MANTOR |
Correspondent |
GENERAL SURGICAL INNOVATIONS |
3172-A PORTER DR. |
PALO ALTO,
CA
94304
|
|
Correspondent Contact |
CATHLEEN MANTOR |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/12/1996 |
Decision Date | 02/19/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|