Device Classification Name |
staple, implantable
|
510(k) Number |
K905106 |
Device Name |
AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
STEVE REITZLER |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
STEVE REITZLER |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 11/13/1990 |
Decision Date | 01/31/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|