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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 K032221
Device Name ADEPT 1064/755 LASER
Applicant
Adept Medical Concepts
29816 Avenida De Las Banderas
Rancho Santa Margarita,  CA  92688
Applicant Contact JERRY MCFARLAND
Correspondent
Adept Medical Concepts
29816 Avenida De Las Banderas
Rancho Santa Margarita,  CA  92688
Correspondent Contact JERRY MCFARLAND
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/21/2003
Decision Date 10/24/2003
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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