Device Classification Name |
suture, absorbable, natural
|
510(k) Number |
K930416 |
Device Name |
SURGICAL SUTURE PACKAGE INSERTS |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
CURTIS RAYMOND |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
CURTIS RAYMOND |
Regulation Number | 878.4830
|
Classification Product Code |
|
Date Received | 01/26/1993 |
Decision Date | 04/28/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|