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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 K854154
Device Name FOX BED MODEL 2001
Applicant
Ace Mfg.
800 Hebron Rd.
Heath,  OH  43056
Applicant Contact ERIC MADINGER
Correspondent
Ace Mfg.
800 Hebron Rd.
Heath,  OH  43056
Correspondent Contact ERIC MADINGER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/11/1985
Decision Date 11/08/1985
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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