Device Classification Name |
Syringe, Piston
|
510(k) Number |
K191659 |
Device Name |
Instylla Delivery Kit |
Applicant |
Instylla, Inc. |
204 Second Avenue |
Waltham,
MA
02451
|
|
Applicant Contact |
Amita Smith |
Correspondent |
Instylla, Inc. |
204 Second Avenue |
Waltham,
MA
02451
|
|
Correspondent Contact |
Amita Smith |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 06/21/2019 |
Decision Date | 10/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|