Device Classification Name |
percussor, powered-electric
|
510(k) Number |
K940986 |
Device Name |
FLUTTER(R) |
Applicant |
VARIORAW, S.A. |
1588 ROUTE 130 NORTH, |
SUITE C-2 |
BRUNSWICK,
NJ
08902
|
|
Applicant Contact |
PATRICIA W BRADSTREET |
Correspondent |
VARIORAW, S.A. |
1588 ROUTE 130 NORTH, |
SUITE C-2 |
BRUNSWICK,
NJ
08902
|
|
Correspondent Contact |
PATRICIA W BRADSTREET |
Regulation Number | 868.5665
|
Classification Product Code |
|
Date Received | 03/01/1994 |
Decision Date | 05/24/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|