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510(k) K911057

DERMATEK 4000 by Anacom General Corp. — Product Code INX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1991
Date Received
March 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Air Fluidized
Device Class
Class II
Regulation Number
890.5160
Review Panel
PM
Submission Type

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