Device Classification Name |
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
|
510(k) Number |
K942620 |
Device Name |
FEATHER-TOUCH SINGLE-STICK DEVICE |
Applicant |
ULSTER SCIENTIFIC, INC. |
P.O. BOX 819 |
NEW PALTZ,
NY
12561 -0819
|
|
Applicant Contact |
DANIEL A GRAFF |
Correspondent |
ULSTER SCIENTIFIC, INC. |
P.O. BOX 819 |
NEW PALTZ,
NY
12561 -0819
|
|
Correspondent Contact |
DANIEL A GRAFF |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 06/02/1994 |
Decision Date | 06/22/1994 |
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
|