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510(k) K952446

TONGUE CLEAN by 1-800-Tongues, Inc. — Product Code LCN

K952446 is an FDA 510(k) premarket notification submitted by 1-800-Tongues, Inc. for the device "TONGUE CLEAN". The FDA issued a decision of Substantially Equivalent on June 22, 1995. The device falls under product code LCN (Scraper, Tongue), a Class I device regulated under 21 CFR 872.6855.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1995
Date Received
May 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scraper, Tongue
Device Class
Class I
Regulation Number
872.6855
Review Panel
DE
Submission Type

Other clearances for product code LCN

  • K992270 — MIRACLEBREATH TONGUE CLEANER (September 23, 1999)
  • K990344 — ORALGIENE TONGUE CLEANER (May 4, 1999)
  • K983683 — UNIK TONGUE CLEANER (January 14, 1999)
  • K983087 — BREATHTIQUE TONGUE SCRAPER (November 18, 1998)
  • K981808 — BREATHAID TONGUE SCRAPER (August 11, 1998)
  • K980842 — COPPER TONGUE SCRAPER (May 20, 1998)
  • K980075 — CYBERSONIC (March 4, 1998)
  • K973424 — ENFRESH TONGUE BRUSH (December 9, 1997)
  • K973175 — TONGUE KLEAN (October 14, 1997)
  • K972644 — BREATH-SO-FRESH TONGUE CLEANER (September 11, 1997)

FDA data resources