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510(k) K060272

LOCOBASE WOUND AND SKIN EMULSION by Ferndale Laboratories, Inc. — Product Code FRO

K060272 is an FDA 510(k) premarket notification submitted by Ferndale Laboratories, Inc. for the device "LOCOBASE WOUND AND SKIN EMULSION". The FDA issued a decision of Substantially Equivalent on January 12, 2007. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2007
Date Received
February 2, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources