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510(k) K103340

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM by Harvest Technologies, Corp. — Product Code JQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2010
Date Received
November 15, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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  • K011032 — SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRA (July 3, 2001)
  • K000456 — HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID AP (June 1, 2000)
  • K991430 — SMARTPREP CENTRIFUGE SYSTEM (May 28, 1999)
  • K983022 — SMARTCELL PROCESSING SYSTEM (April 2, 1999)

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