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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 K023954
Device Name ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
Applicant
Altus Medical, Inc.
821 Cowan Rd.
Burlingame,  CA  94010
Applicant Contact KATHY MAYNOR
Correspondent
Altus Medical, Inc.
821 Cowan Rd.
Burlingame,  CA  94010
Correspondent Contact KATHY MAYNOR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/27/2002
Decision Date 03/18/2003
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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