Device Classification Name |
single use only blood lancet with an integral sharps injury prevention feature
|
510(k) Number |
K933365 |
Device Name |
BABISTICK |
Applicant |
GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. |
BUFFALO,
NY
14240
|
|
Applicant Contact |
JOHN H BARRETT |
Correspondent |
GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. |
BUFFALO,
NY
14240
|
|
Correspondent Contact |
JOHN H BARRETT |
Regulation Number | 878.4850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/09/1993 |
Decision Date | 10/19/1993 |
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
|