Device Classification Name |
endoscopic tissue approximation device
|
510(k) Number |
K934738 |
Device Name |
AUTOSUTURE ENDOSCOPIC SUTURING DEVICE |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
PAUL D SMOLENSKI |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
PAUL D SMOLENSKI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/01/1993 |
Decision Date | 03/16/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|