Device Classification Name |
Suture, Absorbable, Synthetic
|
510(k) Number |
K900198 |
Device Name |
DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. |
Applicant |
AMERICAN CYANAMID CO. |
ONE CASPER ST. |
DANBURY,
CT
06810
|
|
Applicant Contact |
ROBERT I PELLETIER |
Correspondent |
AMERICAN CYANAMID CO. |
ONE CASPER ST. |
DANBURY,
CT
06810
|
|
Correspondent Contact |
ROBERT I PELLETIER |
Regulation Number | 878.4830
|
Classification Product Code |
|
Date Received | 01/16/1990 |
Decision Date | 07/05/1990 |
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
|