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510(k) K043261

HARVEST GRAFT DELIVERY SYRINGE by Harvest Technologies, Corp. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2005
Date Received
November 24, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Harvest Technologies, Corp.

  • K121005 — ADIPREP ADIPOSE TRANSFER SYSTEM (September 21, 2012)
  • K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (December 6, 2010)
  • K052925 — SMARTPREP2 CENTRIFUGE SYSTEM (January 4, 2006)
  • K020252 — SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 (April 5, 2002)
  • 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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