Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K924891 |
Device Name |
PLEXUS PULSER I, PLEXUS PULSER II |
Applicant |
DOBRE, INC. |
2685 CULVER AVE. |
KETTERING,
OH
45429
|
|
Applicant Contact |
ROMAN SZPUR |
Correspondent |
DOBRE, INC. |
2685 CULVER AVE. |
KETTERING,
OH
45429
|
|
Correspondent Contact |
ROMAN SZPUR |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/28/1992 |
Decision Date | 06/07/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|