Device Classification Name |
arterial blood sampling kit
|
510(k) Number |
K950098 |
Device Name |
NEEDLE SAFETY COVER |
Applicant |
HAMMER-PLANE, INC. |
4025 YUMA ST. |
SIMI VALLEY,
CA
93063
|
|
Applicant Contact |
DAVID DELAPLANE |
Correspondent |
HAMMER-PLANE, INC. |
4025 YUMA ST. |
SIMI VALLEY,
CA
93063
|
|
Correspondent Contact |
DAVID DELAPLANE |
Regulation Number | 868.1100
|
Classification Product Code |
|
Date Received | 01/10/1995 |
Decision Date | 08/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|