Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K102512 |
Device Name |
RMS SUBCUTANEOUS NEEDLE SET |
Applicant |
REPRO-MED SYSTEMS, INC. |
24 CARPENTER RD. |
CHESTER,
NY
10918
|
|
Applicant Contact |
ANDREW SEALFON |
Correspondent |
REPRO-MED SYSTEMS, INC. |
24 CARPENTER RD. |
CHESTER,
NY
10918
|
|
Correspondent Contact |
ANDREW SEALFON |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/01/2010 |
Decision Date | 05/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|