Device Classification Name |
Snare, Surgical
|
510(k) Number |
K881224 |
Device Name |
ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE |
Applicant |
ACUFEX MICROSURGICAL, INC. |
575 UNIVERSITY AVE. |
NORWOOD,
MA
02062
|
|
Applicant Contact |
RICHARD E FRANKO |
Correspondent |
ACUFEX MICROSURGICAL, INC. |
575 UNIVERSITY AVE. |
NORWOOD,
MA
02062
|
|
Correspondent Contact |
RICHARD E FRANKO |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 03/22/1988 |
Decision Date | 06/01/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|