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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Imaging
510(k) Number K080788
Device Name VIVASCOPE SYSTEM, MODEL 1500, 3000
Applicant
Lucid, Inc.
2320 Brighton Henrietta
Townline Rd.
Rochester,  NY  14623
Applicant Contact JAMES JOY
Correspondent
Lucid, Inc.
2320 Brighton Henrietta
Townline Rd.
Rochester,  NY  14623
Correspondent Contact JAMES JOY
Regulation Number878.4580
Classification Product Code
PSN  
Date Received03/20/2008
Decision Date 09/17/2008
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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