Device Classification Name |
Arthroscope
|
510(k) Number |
K940985 |
Device Name |
ACUFEX(R) ARTHROPLASTY INSTRUMENTS |
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 | 888.1100 |
Classification Product Code |
|
Date Received | 03/01/1994 |
Decision Date | 05/16/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|