Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K101937 |
Device Name |
HYBRID TROCAR SYSTEM |
Applicant |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
DENISE ADAMS |
Correspondent |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
DENISE ADAMS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/12/2010 |
Decision Date | 08/11/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|