Device Classification Name |
Needle, Aspiration And Injection, Reusable
|
510(k) Number |
K895551 |
Device Name |
ROCKET BONE MARROW NEEDLE |
Applicant |
A & A MEDICAL, INC. |
31A BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Applicant Contact |
CEDRIC K BERNBERG |
Correspondent |
A & A MEDICAL, INC. |
31A BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Correspondent Contact |
CEDRIC K BERNBERG |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 09/13/1989 |
Decision Date | 10/06/1989 |
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
|