Device Classification Name |
Percussor, Powered-Electric
|
510(k) Number |
K946083 |
Device Name |
FLUTTER(R) |
Applicant |
BRADSTREET CLINICAL RESEARCH ASSOC., INC. |
1588 ROUTE 130 NORTH |
SUITE C-2 |
NORTH BRUNSWICK,
NJ
08902
|
|
Applicant Contact |
PATRICIA W BRADSTREET |
Correspondent |
BRADSTREET CLINICAL RESEARCH ASSOC., INC. |
1588 ROUTE 130 NORTH |
SUITE C-2 |
NORTH BRUNSWICK,
NJ
08902
|
|
Correspondent Contact |
PATRICIA W BRADSTREET |
Regulation Number | 868.5665
|
Classification Product Code |
|
Date Received | 12/13/1994 |
Decision Date | 03/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|