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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 K041767
Device Name COOLCUBE COOLPEN
Applicant
Bruce J. Sand M.D.
638 Lindero Canyon Rd. #507
Oak Park,  CA  91377
Applicant Contact BRUCE J SAND, M.D.
Correspondent
Bruce J. Sand M.D.
638 Lindero Canyon Rd. #507
Oak Park,  CA  91377
Correspondent Contact BRUCE J SAND, M.D.
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/30/2004
Decision Date 09/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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