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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K090192
Device Name BILI BLUE F20T12/BBY AND F40T12/BBY
Applicant
Interlectric Corp.
1401 Lexington Ave.
Warren,  PA  16365
Applicant Contact KEN C FRAZIER
Correspondent
Interlectric Corp.
1401 Lexington Ave.
Warren,  PA  16365
Correspondent Contact KEN C FRAZIER
Regulation Number880.5700
Classification Product Code
LBI  
Date Received01/27/2009
Decision Date 04/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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