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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, piston
510(k) Number K191659
Device Name Instylla Delivery Kit
Instylla, Inc.
204 Second Avenue
waltham,  MA  02451
Applicant Contact amita smith
Instylla, Inc.
204 Second Avenue
waltham,  MA  02451
Correspondent Contact amita smith
Regulation Number880.5860
Classification Product Code
Date Received06/21/2019
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