Device Classification Name |
suture, absorbable, natural
|
510(k) Number |
K982646 |
Device Name |
AILEE SUTURES AND AILEE NEEDLES |
Applicant |
MYCO MEDICAL SUPPLIES, INC. |
101 ROSE VALLEY WOODS DR. |
CARY,
NC
27513
|
|
Applicant Contact |
SANJIV KUMAR |
Correspondent |
MYCO MEDICAL SUPPLIES, INC. |
101 ROSE VALLEY WOODS DR. |
CARY,
NC
27513
|
|
Correspondent Contact |
SANJIV KUMAR |
Regulation Number | 878.4830
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/29/1998 |
Decision Date | 06/02/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|