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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 K032797
Device Name DELIGHT DENTAL ER: YAG LASER SYSTEM
Applicant
Hoya Photonics, Inc.
47733 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact THOMAS HANEY
Correspondent
Hoya Photonics, Inc.
47733 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact THOMAS HANEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/08/2003
Decision Date 04/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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