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510(k) K950309

EAGLE by Aalba Dent, Inc. — Product Code EJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1995
Date Received
January 25, 1995
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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  • K972971 — NPG + 2 (January 5, 1998)
  • K973265 — VERABOND 2V (October 16, 1997)
  • K972607 — PLATALLOY (October 10, 1997)
  • K972534 — ALFALLOY (September 5, 1997)
  • K972533 — VERA SOLDER (September 5, 1997)
  • K972118 — VERA PDN (August 15, 1997)

Other clearances for product code EJI

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  • K113247 — ANESTHESIA INJECTION TOOL SET (March 27, 2012)
  • K082249 — MORPHEUS (December 31, 2009)
  • K092943 — ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE (December 11, 2009)
  • K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRAT (March 9, 2009)
  • K081694 — DENJECTOR (September 12, 2008)
  • K061904 — COMPUDENT STA (August 8, 2006)
  • K043322 — MIRAMATIC SAFE SYRINGE SYSTEM (July 21, 2005)