Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K860589 |
Device Name |
INFLATOR/DEFLATOR PISTON SYRINGE |
Applicant |
MICROVASIVE |
31 MAPLE ST. |
MILFORD,
MA
01757
|
|
Applicant Contact |
SAMUEL D WADE |
Correspondent |
MICROVASIVE |
31 MAPLE ST. |
MILFORD,
MA
01757
|
|
Correspondent Contact |
SAMUEL D WADE |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 02/19/1986 |
Decision Date | 04/07/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|