Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K952535 |
Device Name |
ACUFEX ENDOBUTTON TAPE |
Applicant |
ACUFEX MICROSURGICAL, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
FREDERICK TOBIA |
Correspondent |
ACUFEX MICROSURGICAL, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
FREDERICK TOBIA |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 06/01/1995 |
Decision Date | 02/08/1996 |
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
|
Recalls |
CDRH Recalls
|
|
|