Device Classification Name |
Clamp, Umbilical
|
510(k) Number |
K934525 |
Device Name |
AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER |
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 | 884.4530
|
Classification Product Code |
|
Date Received | 09/17/1993 |
Decision Date | 02/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|