Device Classification Name |
Cannula, Surgical, General & Plastic Surgery
|
510(k) Number |
K003965 |
Device Name |
MRI SAFE INSTRUMENTS |
Applicant |
AESCULAP, INC. |
944 MARCON BLVD. |
ALLENTOWN,
PA
18109
|
|
Applicant Contact |
LISA M MILLINGTON |
Correspondent |
AESCULAP, INC. |
944 MARCON BLVD. |
ALLENTOWN,
PA
18109
|
|
Correspondent Contact |
LISA M MILLINGTON |
Regulation Number | 878.4800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/22/2000 |
Decision Date | 03/16/2001 |
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
|
|
|