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510(k) K091287

VS-SENSE TEST by Common Sense , Ltd. — Product Code CEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2009
Date Received
May 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device Class
Class I
Regulation Number
862.1550
Review Panel
CH
Submission Type

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