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510(k) K120026

PERFORMER HT/ HANG&GO HT BASIC by Rand S.R.L. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2012
Date Received
January 3, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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