Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K914967 |
Device Name |
SHARP ENDOKNOT PUSHER |
Applicant |
SHARPE ENDOSURGICAL CORP. |
C/O PALADIN MEDICAL,INC. |
P.O.BOX 560 |
STILL WATER,
MN
55082
|
|
Applicant Contact |
ELAINE DUNCAN |
Correspondent |
SHARPE ENDOSURGICAL CORP. |
C/O PALADIN MEDICAL,INC. |
P.O.BOX 560 |
STILL WATER,
MN
55082
|
|
Correspondent Contact |
ELAINE DUNCAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/05/1991 |
Decision Date | 11/22/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|