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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K911057
Device Name DERMATEK 4000
Applicant
Anacom General Corp.
1335 S. Claudina St.
Anaheim,  CA  92805
Applicant Contact WILLIAM K HAINES
Correspondent
Anacom General Corp.
1335 S. Claudina St.
Anaheim,  CA  92805
Correspondent Contact WILLIAM K HAINES
Regulation Number890.5160
Classification Product Code
INX  
Date Received03/08/1991
Decision Date 04/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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