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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K933146
Device Name ESB 2400 SEI
Applicant
Esb, Inc., Div. of Ray-O-Vac
4150 W. Crystal Lake Rd.
Suite 385
Mchenry,  IL  60051
Applicant Contact STOKES
Correspondent
Esb, Inc., Div. of Ray-O-Vac
4150 W. Crystal Lake Rd.
Suite 385
Mchenry,  IL  60051
Correspondent Contact STOKES
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/29/1993
Decision Date 09/23/1993
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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