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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 K062363
Device Name BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM
Applicant
B&W Tek, Inc.
19 Shea Way, Suite 301
Newark,  DE  19713
Applicant Contact SEAN WANG
Correspondent
B&W Tek, Inc.
19 Shea Way, Suite 301
Newark,  DE  19713
Correspondent Contact SEAN WANG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/10/2006
Decision Date 01/17/2007
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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