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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 K213632
Device Name Instylla Delivery Kit
Applicant
Instylla, Inc.
201 Burlington Rd., N. Bldg.
Bedford,  MA  01730
Applicant Contact Jennifer Greer
Correspondent
Instylla, Inc.
201 Burlington Rd., N. Bldg.
Bedford,  MA  01730
Correspondent Contact Jennifer Greer
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/17/2021
Decision Date 02/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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