Device Classification Name |
Pump, Infusion Or Syringe, Extra-Luminal
|
510(k) Number |
K881707 |
Device Name |
INTROCULAR FLUID INJECTOR |
Applicant |
B&B MEDICAL ASSOC., INC. |
4 CANAL ST. |
DANVERS,
MA
01923
|
|
Applicant Contact |
ALDEN C BERTRAND |
Correspondent |
B&B MEDICAL ASSOC., INC. |
4 CANAL ST. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
ALDEN C BERTRAND |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/11/1988 |
Decision Date | 10/21/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|