Device Classification Name |
Syringe, Balloon Inflation
|
510(k) Number |
K955869 |
Device Name |
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE |
Applicant |
SCIMED LIFE SYSTEMS, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
DIANE M LOWE |
Correspondent |
SCIMED LIFE SYSTEMS, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
DIANE M LOWE |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 12/26/1995 |
Decision Date | 03/22/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|