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510(k) K962941

OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE by Deep Trading Corp. — Product Code LCN

K962941 is an FDA 510(k) premarket notification submitted by Deep Trading Corp. for the device "OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE". The FDA issued a decision of Substantially Equivalent on October 8, 1996. 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
October 8, 1996
Date Received
July 29, 1996
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