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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 K200325
Device Name Orbit Subretinal Delivery System
Applicant
Orbit Biomedical
300 Brookside Ave.
Ambler,  PA  19002
Applicant Contact Stacey Backlund
Correspondent
Clinreg Cnsulting Services, Inc.
733 Bolsana Dr.
Laguna Beach,  CA  92651
Correspondent Contact Debe Deck
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
HMX  
Date Received02/10/2020
Decision Date 07/14/2020
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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