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510(k) K051409

SLIVASURE by Scandinavian Formulas, Inc. — Product Code LED

K051409 is an FDA 510(k) premarket notification submitted by Scandinavian Formulas, Inc. for the device "SLIVASURE". The FDA issued a decision of Substantially Equivalent on August 8, 2005. The device falls under product code LED (Stains, Chemical Solution), a Class I device regulated under 21 CFR 864.1850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2005
Date Received
May 31, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Chemical Solution
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances for product code LED

  • K023046 — SST SALIVA SUPPORTING TABLETS (December 2, 2002)
  • K860795 — SPOTTEST CALCOFLUOR WHITE REAGENT (March 12, 1986)
  • K860319 — MEGACOLOR (February 20, 1986)
  • K860320 — GRANULOCOLOR (February 20, 1986)
  • K860317 — NEUTROCOLOR (February 20, 1986)
  • K860321 — LYSOCOLOR (February 20, 1986)
  • K860316 — PANOPTIKON (February 20, 1986)
  • K854176 — POLYCHROME IV STAIN (October 31, 1985)
  • K851481 — SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (April 29, 1985)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

FDA data resources