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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K230819
Device Name OmniGuide RFID Surgical Laser Fibers
Applicant
Omni-Guide Holdings, Inc.
43 Manning Rd.
Billerica,  MA  01821
Applicant Contact Carlos O Acosta
Correspondent
Omni-Guide Holdings, Inc.
43 Manning Rd.
Billerica,  MA  01821
Correspondent Contact Carlos O Acosta
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/24/2023
Decision Date 04/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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