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510(k) K992995

AROMATIC AND FLAVORED TONGUE DEPRESSOR by Aga Plastic Ind. Com. Ltda. — Product Code FMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1999
Date Received
September 7, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Depressor, Tongue, Non-Surgical
Device Class
Class I
Regulation Number
880.6230
Review Panel
HO
Submission Type

Other clearances by Aga Plastic Ind. Com. Ltda.

  • K101348 — AGACHAMBER SPACER (April 29, 2011)

Other clearances for product code FMA

  • K842461 — TONGUE DEPRESSOR (November 30, 1984)
  • K830705 — MINI LANCET-BLOOD LANCET (April 8, 1983)
  • K821177 — BITE STICK (May 21, 1982)
  • K770120 — MOUTH WASH TRAY (January 28, 1977)