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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 K010715
Device Name AL-40
Applicant
DDC TECHNOLOGIES, INC.
2980 WAVERLY AVE.
OCEANSIDE,  NY  11572
Applicant Contact DMITRY DONSKOY
Correspondent
DDC TECHNOLOGIES, INC.
2980 WAVERLY AVE.
OCEANSIDE,  NY  11572
Correspondent Contact DMITRY DONSKOY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/09/2001
Decision Date 10/04/2001
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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