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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Operating-Room
510(k) Number K001223
Device Name ACULUX, MODEL AX3001, AX3002
Applicant
Aculux
273 S. Airport Pulling Rd.
Naples,  FL  34104
Applicant Contact KIM MARSH
Correspondent
Aculux
273 S. Airport Pulling Rd.
Naples,  FL  34104
Correspondent Contact KIM MARSH
Regulation Number878.4580
Classification Product Code
FQP  
Date Received04/17/2000
Decision Date 06/23/2000
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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