Device Classification Name |
pulse-generator, pacemaker, external
|
510(k) Number |
K033130 |
Device Name |
PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR |
Applicant |
OSYPKA MEDICAL, INC. |
7855 IVANHOE AVE. |
SUITE 226 |
LA JOLLA,
CA
92037
|
|
Applicant Contact |
MARKUS J OSYPKA |
Correspondent |
OSYPKA MEDICAL, INC. |
7855 IVANHOE AVE. |
SUITE 226 |
LA JOLLA,
CA
92037
|
|
Correspondent Contact |
MARKUS J OSYPKA |
Regulation Number | 870.3600
|
Classification Product Code |
|
Date Received | 09/30/2003 |
Decision Date | 10/31/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|