Device Classification Name |
Needle, Spinal, Short Term
|
510(k) Number |
K051860 |
Device Name |
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 |
Applicant |
EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR. |
CROSSROADS BUSINESS PARK |
JOHNSTOWN,
NY
12095
|
|
Applicant Contact |
CHRISTOPHER LAKE |
Correspondent |
EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR. |
CROSSROADS BUSINESS PARK |
JOHNSTOWN,
NY
12095
|
|
Correspondent Contact |
CHRISTOPHER LAKE |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 07/08/2005 |
Decision Date | 08/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|