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510(k) K061242

DERMATHERAPY, MODEL 22216 by Precision Fabrics Group, Inc. — Product Code FMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2007
Date Received
May 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Mattress (Medical Purposes)
Device Class
Class I
Regulation Number
880.6190
Review Panel
HO
Submission Type

Other clearances by Precision Fabrics Group, Inc.

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