Device Classification Name |
needle, aspiration and injection, disposable
|
510(k) Number |
K974741 |
Device Name |
MANAN ACCURA NEEDLE |
Applicant |
MEDICAL DEVICE TECHNOLOGIES, INC. |
4445 SW 35TH TERRACE |
SUITE 310 |
GAINESVILLE,
FL
32608
|
|
Applicant Contact |
KARL SWARTZ |
Correspondent |
MEDICAL DEVICE TECHNOLOGIES, INC. |
4445 SW 35TH TERRACE |
SUITE 310 |
GAINESVILLE,
FL
32608
|
|
Correspondent Contact |
KARL SWARTZ |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 12/19/1997 |
Decision Date | 01/08/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|