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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 K003202
Device Name FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II
Applicant
Altus Medical
821 Cowan Rd.
Burlingame,  CA  94010
Applicant Contact MICHAEL LEVERNIER
Correspondent
Altus Medical
821 Cowan Rd.
Burlingame,  CA  94010
Correspondent Contact MICHAEL LEVERNIER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/12/2000
Decision Date 01/10/2001
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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