Device Classification Name |
introducer, catheter
|
510(k) Number |
K982797 |
Device Name |
BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB |
Applicant |
LUTHER MEDICAL PRODUCTS, INC. |
14332 CHAMBERS RD. |
TUSTIN,
CA
92780 -6912
|
|
Applicant Contact |
KATHLEEN ROBERTS |
Correspondent |
LUTHER MEDICAL PRODUCTS, INC. |
14332 CHAMBERS RD. |
TUSTIN,
CA
92780 -6912
|
|
Correspondent Contact |
KATHLEEN ROBERTS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/10/1998 |
Decision Date | 11/30/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|