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510(k) K092781

MAM TWISTER by Mam International AG — Product Code KKO

K092781 is an FDA 510(k) premarket notification submitted by Mam International AG for the device "MAM TWISTER". The FDA issued a decision of Substantially Equivalent on June 23, 2010. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550. Mam International AG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2010
Date Received
September 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Teething, Fluid-Filled
Device Class
Class II
Regulation Number
872.5550
Review Panel
DE
Submission Type

Other clearances by Mam International AG

  • K093266 — MAM COOLER (July 27, 2010)

Other clearances for product code KKO

  • K123855 — WATER-FILLED TEETHER (May 24, 2013)
  • K110615 — WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE (December 2, 2011)
  • K092025 — FLUID FILLED TEETHER - GEL (January 27, 2011)
  • K093266 — MAM COOLER (July 27, 2010)
  • K092494 — GEL FILLED GUM SOOTHER (March 1, 2010)
  • K093370 — FU HONG INDUSTRIES LIMITED SOOTHER TEETHER (January 21, 2010)
  • K092910 — FLUID-FILLED TEETHER (December 18, 2009)
  • K091198 — LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962 (December 7, 2009)
  • K090167 — PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS (June 18, 2009)
  • K082824 — FLUID FILLED TEETHER (May 27, 2009)

FDA data resources