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510(k) K082755

SEDAT FLAMINGO by Sedat — Product Code MAV

K082755 is an FDA 510(k) premarket notification submitted by Sedat for the device "SEDAT FLAMINGO". The FDA issued a decision of Substantially Equivalent on December 15, 2008. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Sedat has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2008
Date Received
September 19, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

Other clearances by Sedat

  • K080472 — SEDAT MYSHELL LITE (April 23, 2008)
  • K060010 — NAUTIFLUX (August 4, 2006)
  • K042449 — DOLPHIN INFLATION DEVICE (April 18, 2005)
  • K040498 — MYSHELL (July 2, 2004)

Other clearances for product code MAV

  • K260035 — Digital Indeflator INFLANTE (September 4, 2026)
  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • K162272 — Fluent inflation device (October 20, 2016)
  • K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disp (April 13, 2016)
  • K153672 — basixTOUCH40 Inflation Syringe (January 20, 2016)
  • K152387 — Fluent Inflation Device (December 18, 2015)
  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 2015)
  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K140745 — ENCORE 26 ADVANTAGE KIT (April 17, 2014)

FDA data resources