Device Classification Name |
pneumoperitoneum needle
|
510(k) Number |
K010779 |
Device Name |
MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT |
Applicant |
GIBBONS SURGICAL CORP. |
1112 JENSEN DRIVE, STE.101 |
VIRGINIA BEACH,
VA
23451
|
|
Applicant Contact |
LISA CRISSON |
Correspondent |
GIBBONS SURGICAL CORP. |
1112 JENSEN DRIVE, STE.101 |
VIRGINIA BEACH,
VA
23451
|
|
Correspondent Contact |
LISA CRISSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/15/2001 |
Decision Date | 04/10/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|