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510(k) K100613

BIOMED WOUND CLEANSER by Biomed Laboratories, Inc. — Product Code FRO

K100613 is an FDA 510(k) premarket notification submitted by Biomed Laboratories, Inc. for the device "BIOMED WOUND CLEANSER". The FDA issued a decision of Substantially Equivalent on January 5, 2011. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2011
Date Received
March 4, 2010
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