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510(k) K161613

Hang&Go PAC by Rand S.R.L. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2016
Date Received
June 10, 2016
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

Other clearances by Rand S.R.L.

  • K120026 — PERFORMER HT/ HANG&GO HT BASIC (May 8, 2012)
  • K070213 — PERFORMER CBP SYSTEM (March 21, 2007)
  • K052555 — MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB (March 15, 2006)

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