Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K970416 |
Device Name |
ACUFEX DOUBLE ARMED SUTURE NEEDLE |
Applicant |
SMITH & NEPHEW ENDOSCOPY, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
SUSAN A FINNERAN |
Correspondent |
SMITH & NEPHEW ENDOSCOPY, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
SUSAN A FINNERAN |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 02/04/1997 |
Decision Date | 04/21/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|