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510(k) K120659

HU-FRIEDY DENTAL CARTRIDGE SYRINGE by Hu-Friedy Mfg. Co., LLC — Product Code EJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2012
Date Received
March 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type

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  • K012060 — MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT (July 27, 2001)
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  • K912473 — ACCU-PLACER TM KIT (July 24, 1991)
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  • K081694 — DENJECTOR (September 12, 2008)
  • K061904 — COMPUDENT STA (August 8, 2006)
  • K043322 — MIRAMATIC SAFE SYRINGE SYSTEM (July 21, 2005)
  • K040671 — EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING (December 14, 2004)