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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 K203264
Device Name MicroDose Injector
Applicant
Medone Surgical, Inc.
670 Tallevast Rd.
Sarasota,  FL  34243
Applicant Contact Bruce Beckstein
Correspondent
Elkin Rc, LLC
42 N. Chantsong Cir.
The Woodlands,  TX  77382
Correspondent Contact Darla Elkin
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/05/2020
Decision Date 04/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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