Device Classification Name |
Sound, Uterine
|
510(k) Number |
K883806 |
Device Name |
ROCKET INTRAUTERINE SOUND |
Applicant |
A & A MEDICAL, INC. |
31A BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Applicant Contact |
K BERNBERG |
Correspondent |
A & A MEDICAL, INC. |
31A BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Correspondent Contact |
K BERNBERG |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/07/1988 |
Decision Date | 10/31/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|