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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 K864907
Device Name SUNTANNING LAMP
Applicant
Interlectric Corp.
1401 Lexington Ave.
Warren,  PA  16365
Applicant Contact DAVID E COCHENER
Correspondent
Interlectric Corp.
1401 Lexington Ave.
Warren,  PA  16365
Correspondent Contact DAVID E COCHENER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/15/1986
Decision Date 01/05/1987
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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